MICROBIOLOGY

CONTROL PRODUCTS
MOLECULAR QC MICROORGANISMS
TABLE OF CONTENTS
TABLE OF CONTENTS

About Microbiologics 1

Customer Information 2

Products by Molecular Syndromic Testing

Blood Culture Identification (BCID) 3
Gastrointestinal (GI) 9
Healthcare-Associated Infections (HAIs) 16
Respiratory Pathogens 21
Women’s Health and Sexually Transmitted Infections (STI) 30
Emerging Diseases and Other Pathogens 37
All Products
Inactivated Helix Elite™ Molecular Standards 40
Negative Cellularity Controls 40
Synthetic Helix Elite Molecular Standards
™
43
QC Sets and Panels 45
Assay-Specific QC Sets and Panels 46
Syndrome-Specific QC Sets and Panels 47
Payment and Shipping Information 49

BRO19 Rev B Microbiologics Molecular Controls

ABOUT MICROBIOLOGICS
MICROBIOLOGICS.COM
In support of our commitment to quality service, we have designed our website to be a helpful, easy-to-use
resource for customers. The website is updated regularly and is the best place to obtain the most current
information. Listed below are examples of the resources available:

• Digital catalog • Instructions for Use (multiple translations)

• Product descriptions and applications • Locate a distributor by country
• End user registration • Safety Data Sheets (multiple translations)
• Certificates of Analysis and Certificates of • Customer & Technical Support documents
Performance • Easy-to-use product and document search
• Online ordering • Frequently asked questions (FAQs)
• Contact Us form • Order management

CUSTOMER SERVICE
We take pride in providing you with exceptional customer service. Customer calls are answered by a team of
experts ready to assist you with everything from account set up to placing an order.

All international customers should contact an authorized distributor for ordering information. Locate a distributor
in your area by visiting microbiologics.com. If an authorized distributor is not listed in your country, please contact
Microbiologics Customer Service.

TECHNICAL SUPPORT
Our team of experienced Technical Support experts are always eager to help customers use our product
successfully. They can provide guidance for selecting the right strains and product formats for your unique testing
needs, and help problem solve when issues arise in your lab.

Contact Customer Service Contact Technical Support

Hours 7:30 a.m. - 5 p.m. (CST) Hours 8:00 a.m. - 5 p.m. (CST)

Phone 1.320.253.1640 Phone 1.320.229.7045

US Toll Free 800.599.2847 US Toll Free 866.286.6691

Fax 320.253.6250 Fax 320.253.6250

Email [email protected] Email [email protected]

SAFE, SIMPLE, STABLE CONTROLS

Microbiologics products are compatible with a variety of instruments, kits and applications. Our independent
external controls provide accurate, reliable results with convenient test-ready formats save you time and money.
Our controls offer easy and economical storage with no freezing required.

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CUSTOMER INFORMATION
WORLDWIDE DISTRIBUTION
Our extensive distribution network allows us to reach every corner of the world, from Afghanistan to Zambia. We
select distributors that are customer focused and demonstrate a commitment to our mission of providing the highest
quality biomaterials for a safer, healthier world. Locate a distributor in your area by visiting microbiologics.com.

INTERNATIONAL CUSTOMERS
All international customers must contact an authorized distributor within their country to place an order. To search
for distributors by country, visit microbiologics.com. If an authorized distributor is not listed in your country, please
contact Microbiologics Customer Service at [email protected] or +1 320.253.1640.

US CUSTOMERS
Customers located in the United States may purchase Microbiologics products directly or through an authorized
distributor. Visit microbiologics.com to search for distributors in the United States. Orders can be placed online
at microbiologics.com or by contacting Customer Service. Be prepared to provide the following information with
your order:

• Customer account number • Purchase order number

• Registration number • Credit card information
• Billing address • Tax exemption information (certified exemption
• Telephone number form must be kept on file)
• Email address • Quantities
• Fax number • Microbiologics catalog number or reference culture
• Shipping address numbers

Online orders can be placed at microbiologics.com by signing in on the homepage or clicking “Register” to create
an account.

PRODUCT WARRANTY
Microbiologics guarantees results when the product is stored, handled and used as directed (as per the expiration
date, Microbiologics Recommended Growth Requirements, Illustrated Instructions and Instructions for Use). Please
report concerns to Microbiologics Technical Support immediately. For more information, see the document titled
Product Warranty and Product Replacement located at microbiologics.com.

END USER REGISTRATION

An authorized representative from your organization must agree to the terms of the End User Agreement in order
to receive Microbiologics biological materials.

Registration can be completed at microbiologics.com. Contact Customer Service at 1.320.253.1640 or info@

microbiologics.com with questions about the End User Agreement.

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BLOOD CULTURE
IDENTIFICATION
Diagnosing sepsis and bloodstream infections requires fast, accurate laboratory results for swift and
proper treatment. To help clinical labs ensure their blood culture identification (BCID) instruments
and assays are consistently producing reliable results, we offer a variety of verification and quality
control panels designed for efficiency and usability.

Page 3 of 47
BLOOD CULTURE IDENTIFICATION PANELS

Blood Culture Identification (BCID)

Control Panel (Inactivated) – Catalog #8215
Contains six inactivated, pre-pooled pellets comprised
of the microorganisms listed below. Also included is
six blank negative control pellets.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- Acinetobacter baumannii - Klebsiella pneumoniae (KPC)

- Candida albicans - Listeria monocytogenes serovar 7
- Candida glabrata - Neisseria meningitidis
- Candida krusei - Proteus vulgaris
- Candida parapsilosis - Pseudomonas aeruginosa
- Candida tropicalis - Serratia marcescens
- Enterobacter cloacae - Staphylococcus aureus (MRSA)
- Enterococcus faecalis (vanB) - Staphylococcus epidermidis (MSSE)
- Escherichia coli - Streptococcus agalactiae
- Haemophilus influenzae - Streptococcus pneumoniae
- Klebsiella oxytoca - Streptococcus pyogenes

Blood Culture Identification (BCID) Verification Panel (Inactivated) – Catalog #8201

Contains one inactivated, pre-pooled microorganism pellet of each pool listed below (three vials
total) and three vials of molecular hydration buffer. Once rehydrated, each vial contains enough
material for five uses and can be used for up to 72 hours when refrigerated.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Pool 1 (One pellet/kit) Pool 2 (One pellet/kit) Pool 3 (One pellet/kit)

- Candida albicans - Acinetobacter baumannii - Candida parapsilosis

- Candida krusei - Candida glabrata - Haemophilus influenzae
- Neisseria meningitidis - Candida tropicalis - Klebsiella pneumoniae (KPC)
- Pseudomonas aeruginosa - Enterobacter cloacae - Proteus vulgaris
- Staphylococcus aureus (MRSA) - Enterococcus faecalis (vanB) - Serratia marcescens
- Streptococcus agalactiae - Escherichia coli - Streptococcus pneumoniae
- Streptococcus pyogenes - Klebsiella oxytoca
- Listeria monocytogenes serovar 7
- Staphylococcus epidermidis (MSSE)

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BLOOD CULTURE IDENTIFICATION PANELS

Blood Culture Identification (BCID) Verification

Panel (Live Culture) – Catalog #5229P

Contains two KWIK-STIKs of each strain listed below

(44 KWIK-STIKs total).

- 0357 Acinetobacter baumannii derived from ATCC® 19606™*

- 0443 Candida albicans derived from ATCC® 10231™*
- 0737 Candida glabrata derived from ATCC® 15126™*
- 0809 Candida krusei derived from ATCC® 14243™*
- 0726 Candida parapsilosis derived from ATCC® 22019™*
- 01036 Candida tropicalis derived from ATCC® 1369™*
- 0323 Enterobacter cloacae subsp. cloacae derived from ATCC® 13047™*
- 0959 Enterococcus faecalis derived from ATCC® 51299™* (vanB positive, resistant to vancomycin)
- 0681 Escherichia coli derived from ATCC® 11229™*
- 0441 Haemophilus influenzae derived from ATCC® 10211™* (type b and beta lactamase negative)
- 0530 Klebsiella oxytoca derived from ATCC® 13182™*
- 01005 Klebsiella pneumoniae derived from ATCC® BAA-1705™*
- 0277 Listeria monocytogenes derived from ATCC® 19111™* (serotype 1)
- 0453 Neisseria meningitidis derived from ATCC® 13077™* (serogroup A)
- 0944 Proteus mirabilis derived from ATCC® 35659™*
- 0353 Pseudomonas aeruginosa derived from ATCC® 27853™*
- 0247 Serratia marcescens derived from ATCC® 13880™*
- 0496 Staphylococcus aureus subsp. aureus derived from ATCC® 33591™* (methicillin resistant)
- 0371 Staphylococcus epidermidis derived from ATCC® 12228™*
- 0439 Streptococcus agalactiae derived from ATCC® 12386™* (group B)
- 0865 Streptococcus pneumoniae derived from ATCC® 10015™*
- 0385 Streptococcus pyogenes derived from ATCC® 19615™* (group A)
*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem,
the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use
these trademarks and to sell products derived from ATCC® cultures.

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BLOOD CULTURE IDENTIFICATION PANELS

Blood Culture Identification 2 (BCID2) Verification

Panel (Live Culture) – Catalog #5258P

Contains two KWIK-STIKs of each strain listed below

(70 KWIK-STIKs total).

- 0217 Staphylococcus lugdunensis derived from ATCC® 49576™*

- 0247 Serratia marcescens derived from ATCC® 13880™*
- 0277 Listeria monocytogenes derived from ATCC® 19111™*
- 0320 Bacteroides fragilis derived from ATCC® 25285™*
- 0323 Enterobacter cloacae subsp. cloacae derived from ATCC® 13047™*
- 0353 Pseudomonas aeruginosa derived from ATCC® 27853™*
- 0357 Acinetobacter baumannii derived from ATCC® 19606™*
- 0371 Staphylococcus epidermidis derived from ATCC® 12228™*
- 0385 Streptococcus pyogenes derived from ATCC® 19615™*
- 0399 Klebsiella aerogenes derived from ATCC® 35029™*
- 0439 Streptococcus agalactiae derived from ATCC® 12386™*
- 0441 Haemophilus influenzae derived from ATCC® 10211™*
- 0443 Candida albicans derived from ATCC® 10231™*
- 0453 Neisseria meningitidis derived from ATCC® 13077™*
- 0496 Staphylococcus aureus subsp. aureus derived from ATCC® 33591™*
- 0530 Klebsiella oxytoca derived from ATCC® 13182™*
- 0726 Candida parapsilosis derived from ATCC® 22019™*
- 0737 Candida glabrata derived from ATCC® 15126™*
- 0759 Stenotrophomonas maltophilia derived from ATCC® 17666™*
- 0809 Candida krusei derived from ATCC® 14243™*
- 0865 Streptococcus pneumoniae derived from ATCC® 10015™*
- 0901 Salmonella enterica subsp. arizonae derived from ATCC® 13314™*
- 0944 Proteus mirabilis derived from ATCC® 35659™*
- 0959 Enterococcus faecalis derived from ATCC® 51299™*
- 0985 Cryptococcus neoformans derived from ATCC® 66031™*
- 01005 Klebsiella pneumoniae derived from ATCC® BAA-1705™*
- 01036 Candida tropicalis derived from ATCC® 1369™*
- 01051 Cryptococcus gattii derived from ATCC® MYA-4560™*
- 01112 Klebsiella pneumoniae derived from NCTC 13440
- 01136 Escherichia coli derived from NCTC 13476
- 01143 Enterococcus faecium derived from NCTC 12204
- 01145 Klebsiella pneumoniae derived from NCTC 13443
- 01241 Klebsiella pneumoniae derived from CDC AR-0039
- 01256 Candida auris derived from CDC B11903
- 01259 Escherichia coli derived from CDC AR-0346
*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem,
the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use
these trademarks and to sell products derived from ATCC® cultures.

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BLOOD CULTURE IDENTIFICATION PANELS

Gram-Positive Blood Culture Control Panel

(Inactivated Pellet) – Catalog #8180
Contains five inactivated microorganism pellets of each
pool listed below (15 pellets/kit total).

• Refrigerated storage
• For in vitro diagnostic use
• International restrictions may apply

Pool 1 (Five pellets/kit) Pool 2 (Five pellets/kit) Pool 3 (Five pellets/kit)

- Enterococcus faecium - Streptococcus agalactiae - Staphylococcus aureus

- Listeria monocytogenes - Streptococcus anginosus - Enterococcus faecalis
- Staphylococcus epidermidis - Streptococcus pyogenes - Streptococcus pneumoniae
- Staphylococcus lugdunensis

Gram-Positive Blood Culture Control Panel

(Live Culture) – Catalog #5225P
Contains two KWIK-STIKs of each strain listed below
(20 KWIK-STIKs total).

- 0714 Enterococcus faecalis derived from NCTC 13379

- 01143 Enterococcus faecium derived from NCTC 12204
- 0783 Listeria monocytogenes derived from NCTC 10890
- 01065 Staphylococcus aureus derived from NCTC 12493
- 0571 Staphylococcus epidermidis derived from NCIMB 8853
- 01150 Staphylococcus lugdunensis derived from NCTC 7990
- 0480 Streptococcus agalactiae derived from NCTC 8017
- 0389 Streptococcus anginosus derived from NCTC 10713
- 0469 Streptococcus pneumoniae derived from NCIMB 13286
- 0314 Streptococcus pyogenes derived from NCIMB 13285

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BLOOD CULTURE IDENTIFICATION PANELS

Gram-Negative Blood Culture Control Panel

(Inactivated Pellet) – Catalog #8181

Contains five inactivated microorganism pellets of

each pool listed below (15 pellets/kit total).

• Refrigerated storage
• For in vitro diagnostic use
• International restrictions may apply

Pool 4 (Five pellets/kit) Pool 5 (Five pellets/kit) Pool 6 (Five pellets/kit)

- Acinetobacter baumannii - Klebsiella pneumoniae - Klebsiella oxytoca

- Pseudomonas aeruginosa - Citrobacter freundii - Klebsiella pneumoniae
- Enterobacter cloacae - Escherichia coli - Proteus vulgaris
- Klebsiella pneumoniae
- Klebsiella pneumoniae

Gram-Negative Blood Culture Control Panel

(Live Culture) – Catalog #5226P
Contains two KWIK-STIKs of each strain listed below
(24 KWIK-STIKs total).

- 0599 Acinetobacter baumannii derived from NCIMB 12457

- 0574 Citrobacter freundii derived from NCTC 9750
- 01105 Enterobacter cloacae derived from NCTC 13464
- 01136 Escherichia coli derived from NCTC 13476
- 01117 Klebsiella pneumoniae derived from NCTC 13438
- 01148 Klebsiella pneumoniae derived from NCTC 13442
- 01145 Klebsiella pneumoniae derived from NCTC 13443
- 01112 Klebsiella pneumoniae derived from NCTC 13440
- 01147 Klebsiella oxytoca derived from NCTC 11686
- 0393 Proteus vulgaris derived from NCTC 4636
- 0830 Pseudomonas aeruginosa derived from NCTC 10662
- 01146 Serratia marcescens derived from NCTC 9743

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GASTROINTESTINAL (GI)
With the broad array of viruses, bacteria, and parasites that can cause gastrointestinal (GI) infections,
diagnosis can sometimes feel like a guessing game. Microbiologics offers easy-to-use verification
and control panels for rapid diagnostic instruments and multiplex assays designed for detecting
gastrointestinal pathogens. Because QC testing shouldn’t be another mystery.

Page 9 of 47
ASSAY-SPECIFIC PANELS FOR GI TESTING

BD MAX™ Enteric Parasite 20-Day QC Panel

– Catalog #8202
Contains 20 inactivated, pre-pooled microorganism
pellets comprised of the organisms recommended
by the manufacturer for QC listed below (20 pellets/
kit total). For use with the BD MAX™ Enteric
Parasite Panel

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- Cryptosporidium parvum
- Giardia lamblia
- Entamoeba histolytica surrogate

BD MAX™ Enteric Parasite Control Panel –

Catalog #8204
Contains six inactivated, pre-pooled microorganism
pellets comprised of the organisms recommended
by the manufacturer for QC listed below (six pellets/
kit total). For use with the BD MAX™ Enteric
Parasite Panel

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- Cryptosporidium parvum
- Giardia lamblia
- Entamoeba histolytica surrogate

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GASTROINTESTINAL PANELS

Enteric Bacterial Organism Set (Live Culture) –

Catalog #8179
Contains two KWIK-STIKs of each strain listed below
(16 KWIK-STIKs total).

• Export license required for shipping outside the U.S.

• UN2814 Hazardous

- 0356 Shigella flexneri derived from ATCC® 12022™*

- 0363 Salmonella enterica subsp. enterica serovar Typhimurium derived from ATCC® 14028™*
- 0446 Shigella sonnei derived from ATCC® 9290™*
- 0481 Campylobacter jejuni subsp. jejuni derived from ATCC® 33291™*
- 0595 Salmonella bongori derived from ATCC® 43975™*
- 01023 Campylobacter coli derived from ATCC® 33559™*
- 01102 Escherichia coli serotype O111:H8 derived from CDC 2010C-3114 (STEC)
- 01204 Escherichia coli (O157:H7) derived from ATCC® 43890™* (STEC)
*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem,
the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use
these trademarks and to sell products derived from ATCC® cultures.

Enteric Parasite Verification Panel (Synthetic)

– Catalog #8182

Contains five vials of dried synthetic DNA and one

vial of molecular standard water for rehydration. Each
vial is comprised of pooled Cryptosporidium spp.,
Entamoeba histolytica and Giardia lamblia synthetic
DNA. No additional mixing or dilution required.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply
• Not CE Marked

Enteric Parasite Control Panel (Inactivated

Pellet) – Catalog #8230

Contains six inactivated, pre-pooled microorganism

pellets comprised of the organisms listed below (six
pellets/kit total).

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- Cryptosporidium parvum
- Entamoeba histolytica surrogate
- Giardia lamblia

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GASTROINTESTINAL PANELS

Enteric Pathogens Control Panel (Inactivated Pellet)

– Catalog #8184
Contains five inactivated microorganism pellets of each pool
listed below (10 pellets/kit total).

• Refrigerated storage
• For in vitro diagnostic use
• Export license required for shipping outside the U.S.

Pool 7/Positive Control (Five pellets/kit)

- Campylobacter jejuni
- Shigella sonnei
- Yersinia enterocolitica
- Salmonella enterica subsp. enterica serovar Typhimurium
- Vibrio parahaemolyticus
- Escherichia coli (shiga toxin 1, shiga toxin 2)
- Rotavirus SA11
- Norovirus GII.4 surrogate

Pool 8/Negative Control (Five pellets/kit)

- Clostridioides difficile (NAP1)

Enteric Viral Verification Panel – Catalog #8210

Contains 20 inactivated, pre-pooled microorganism pellets
comprised of the organisms listed below (20 pellets/kit total).

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- Adenovirus 40 - Rotavirus
- Astrovirus surrogate - Sapovirus surrogate
- Norovirus GII surrogate

Enteric Viral Control Panel – Catalog #8211

Contains six inactivated, pre-pooled microorganism pellets
comprised of the organisms listed below (six pellets/kit total).

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- Adenovirus 40 - Rotavirus
- Astrovirus surrogate - Sapovirus surrogate
- Norovirus GII surrogate

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GASTROINTESTINAL PANELS

Extended Enteric Bacterial Verification Panel

(Inactivated Pellet) – Catalog #8191
Contains 21 inactivated, pre-pooled microorganism
pellets comprised of the organisms listed below
(21 pellets/kit total).

• Room temperature storage

• For in vitro diagnostic use
• Export license required for shipping outside the U.S.

- Salmonella enterica serovar Typhimurium derived from NCTC 74

- Shigella sonnei derived from NCTC 12984
- Escherichia coli derived from CDC 2010C-3114
(STEC, serotype O111:H8, eae positive, stx 1 and/or stx 2 positive)
- Campylobacter jejuni derived from NCTC 11322
- Plesiomonas shigelloides derived from NCTC 10363
- Yersinia enterocolitica derived from NCTC 11174 (biotype 2, serotype 9)
- Escherichia coli derived from NCTC 11602 (ETEC, serovar o159:h34)
- Vibrio parahaemolyticus derived from NCTC 13209 (VP81, serotype O3:K6)

Comprehensive Enteric Bacterial Control Panel

(Inactivated Pellet) – Catalog #8231
Contains six inactivated, pre-pooled microorganism pellets
comprised of the organisms listed below (six pellets/kit total).

• Room temperature storage

• For in vitro diagnostic use
• Export license required for shipping outside the U.S.

- Salmonella enterica serovar Typhimurium derived from NCTC 74

- Shigella sonnei derived from NCTC 12984
- Escherichia coli derived from CDC 2010C-3114
(STEC, serotype O111:H8, eae positive, stx 1 and/or stx 2 positive)
- Campylobacter jejuni derived from NCTC 11322
- Plesiomonas shigelloides derived from NCTC 10363
- Yersinia enterocolitica derived from NCTC 11174 (biotype 2, serotype 9)
- Escherichia coli derived from NCTC 11602 (ETEC, serovar o159:h34)
- Vibrio parahaemolyticus derived from NCTC 13209 (VP81, serotype O3:K6)

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GASTROINTESTINAL PANELS

Norovirus Control Panel (Inactivated Swab) –

Catalog #8205

Contains six positive and six negative inactivated

control swabs (12 swabs total) comprised of the strains
listed below.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six swabs/kit):

- Norovirus GI.1 (ORF1-ORF2) surrogate
- Norovirus GII.4 (ORF1-ORF2) surrogate

Negative Control (Six swabs/kit):

- Rotavirus

Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)

– Catalog #8236
Contains six pellets of Positive Control 1, six pellets of Positive Control 2,
and 12 negative control pellets (24 pellets/kit total). The negative control
pellets are blank and do not contain microorganisms.

• Room temperature storage

• For in vitro diagnostic use
• Export license required for shipping outside the U.S.

Positive Control 1 (Six pellets/kit) Positive Control 2 (Six pellets/kit)

- Campylobacter jejuni - Salmonella Typhimurium
- Clostridioides (Clostridium) difficile - Vibrio cholerae
- Plesiomonas shigelloides - Escherichia coli (EPEC)
- Yersinia enterocolitica - Escherichia coli (ETEC)
- Escherichia coli (STEC) - Cyclospora cayetanensis surrogate
- Escherichia coli (EAEC) surrogate - Entamoeba histolytica surrogate
- Escherichia coli (O157) - Giardia lamblia
- Shigella sonnei - Astrovirus surrogate
- Cryptosporidium parvum - Norovirus GI surrogate
- Adenovirus - Norovirus GII surrogate
- Sapovirus surrogate - Rotavirus A

Negative Control (Twelve pellets/kit)

- Blank pellets

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HELIX ELITE™ MOLECULAR STANDARDS FOR (GI) TESTING

Inactivated Helix Elite Molecular Standards

Full process controls for use in molecular testing. Each

kit contains five unassayed inactivated microorganism
pellets packaged in individual vials for ease-of-use and
to avoid cross contamination.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Inactivated Rotavirus – Catalog #HE0027N

• Medium-high titer
• Strain Simian Rotavirus SA11

Synthetic Helix Elite Molecular Standards

For use as a positive control in molecular applications.

Each kit contains one vial of dried synthetic DNA or
RNA (up to 100 reactions), and one vial of molecular
standard water for rehydration.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply
• Dried RNA Preserved with Biomatrica RNAstable®

Norovirus GI.1 Synthetic RNA – Norovirus GII.4 Synthetic RNA –

Catalog #HE0013S Catalog #HE0012S
• ORF1-ORF2 Junction of Norovirus GI.1 • ORF1-ORF2 Junction of Norovirus GII.4

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HEALTHCARE-ASSOCIATED
INFECTIONS (HAIs)
When it comes to detecting and identifying healthcare-associated infections (HAIs), there is no room
for error. Microbiologics offers simple, reliable controls for HAI testing in clinical laboratories to
ensure procedures and materials are working properly.

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ASSAY-SPECIFIC PANELS FOR HAI TESTING

Cepheid Xpert® C. difficile/Epi Control Panel

(Inactivated Swab) – Catalog #8200
Contains six positive and six negative inactivated
control swabs (12 swabs total) comprised of the
organisms recommended by the manufacturer for QC.
For use with Cepheid Xpert® C. difficile/Epi assay

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply
• Not CE Marked

Positive Control (six swabs/kit):

- Clostridium difficile (NAP1/027)

Negative Control (six swabs/kit):

- Clostridium sordellii

Cepheid Xpert® MRSA NxG Control Panel – Catalog #8195

Contains six positive and six negative inactivated control swabs (12 swabs total) comprised of the
organisms recommended by the manufacturer for QC. For use with Cepheid Xpert® MRSA NxG assay.

• Room temperature storage Positive Control (Six swabs):

• For in vitro diagnostic use - Methicillin-resistant Staphylococcus aureus
• International restrictions may apply
• Not CE Marked Negative Control (Six swabs):
- Staphylococcus epidermidis

Cepheid Xpert® SA Nasal Complete Control Panel – Catalog #8196

Contains 12 positive and six negative inactivated control swabs (18 swabs total) comprised of the
organisms recommended by the manufacturer for QC. For use with Cepheid Xpert® SA Nasal
Complete assay.

• Room temperature storage Positive Control 1 (Six swabs/kit):

• For in vitro diagnostic use - Methicillin-resistant Staphylococcus aureus
• International restrictions may apply
• Not CE Marked Positive Control 2 (Six swabs/kit):
- Staphylococcus aureus

Negative Control (Six swabs/kit):

- Staphylococcus epidermidis

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SYNDROME-SPECIFIC PANELS FOR HAI TESTING

C. difficile Verification Panel (Live Culture)

– Catalog #8243
Contains two KWIK-STIKs of each strain listed
below (four KWIK-STIKs total).

- 0527 Clostridioides difficile ATCC® 700057™*

- 0329 Clostridioides difficile ATCC® 9689™*

*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem,
the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use
these trademarks and to sell products derived from ATCC® cultures.

C. difficile Control Panel (Inactivated Swab) – Catalog #8227

Contains six positive and six negative inactivated control swabs.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six swabs/kit):

- Clostridioides difficile

Negative Control (Six swabs/kit):

- Clostridium sordellii

C. difficile QC Set (Live Culture) – Catalog #8171

Contains one KWIK-STIK™ unit of Clostridioides difficile
derived from ATCC® 9689™* and one KWIK-STIK™ unit of
Clostridioides difficile derived from ATCC® 700057™*
two total.

*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem,
the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use
these trademarks and to sell products derived from ATCC® cultures.

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SYNDROME-SPECIFIC PANELS FOR HAI TESTING

Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel (Inactivated Swab) –

Catalog #8187
Contains six pre-pooled positive and six negative inactivated control swabs (12 swabs total)
comprised of the organisms listed below.

Positive Control (Six swabs/kit): • Room temperature storage

- Escherichia coli derived from NCTC 13476 (IMP-type) • For in vitro diagnostic use
- Klebsiella pneumoniae derived from NCTC 13440 • International restrictions may apply
(VIM-1, Metallo-beta-lactamase positive)
- Klebsiella pneumoniae derived from NCTC 13443
(DM-1 positive, New Delhi metallo-beta-lactamase)
- Klebsiella pneumoniae derived from NCTC 13438
(Produces carbapenemase KPC-3)
- Klebsiella pneumoniae derived from NCTC 13442 (OXA-48)

Negative Control (Six swabs/kit):

- Escherichia coli derived from NCTC 11954

MRSA Organism Set (Live Culture) – Catalog #8174

Contains four KWIK-STIK™ units of each microorganism listed below.

- Staphylococcus aureus derived from ATCC® 33591™*
- Staphylococcus aureus derived from ATCC® 700699™*
- Staphylococcus aureus derived from ATCC® 43300™*
- Staphylococcus aureus derived from ATCC® 700698™*
- Staphylococcus aureus derived from NCTC 12493
- Staphylococcus aureus subsp. aureus derived from NCTC 12973
- Staphylococcus aureus derived from ATCC® 6538™*
- Staphylococcus aureus derived from ATCC® 29213™*
- Staphylococcus aureus subsp. aureus derived from ATCC® 33862™*
- Staphylococcus epidermidis derived from ATCC® 51625™*
*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem,
the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use
these trademarks and to sell products derived from ATCC® cultures.

SA Organism Set (Live Culture) – Catalog #8178

Contains 14 Staphylococcal strains, one KWIK-STIK of each strain (14 KWIK-STIKs total).
- 11 strains/KWIK-STIKs: Methicillin-Resistant Staphylococcus aureus (MRSA)
- Two strains/KWIK-STIKs: Methicillin-Sensitive Staphylococcus aureus (MSSA)
- One strain/KWIK-STIKs: Methicillin-Sensitive Staphylococcus epidermidis (MSSE)

BRO19 Rev D Microbiologics Molecular Controls Page 19 of 49

SYNDROME-SPECIFIC PANELS FOR HAI TESTING

Live Culture Staphylococcus Controls

Each kit contains two KWIK-STIKs at E4 concentration.

- Staphylococcus aureus subsp. aureus derived from ATCC® 25923™*

(MSSA Live Culture Positive Control) - Catalog #0360MSSA
- Staphylococcus aureus subsp. aureus derived from ATCC® 700699™*
(MRSA Live Culture Positive Control) - Catalog #0158MRSA
- Staphylococcus epidermidis derived from ATCC® 12228™*
(MSSE Live Culture Positive Control) - Catalog #0371MSSE
*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem,
the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use
these trademarks and to sell products derived from ATCC® cultures.

Vancomycin Resistant Enterococcus (VRE) Control Panel

(Inactivated Swab) – Catalog #8203
Contains six positive and six negative inactivated control swabs (12 swabs total)
comprised of the strains listed below.
• Room temperature storage
• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six swabs/kit): Enterococcus faecium

(vanA-type glycopeptide resistance and Vancomycin resistant)

Negative Control (Six swabs/kit): Enterococcus faecalis

Methicillin-Resistant Staphylococcus aureus (MRSA) Inactivated Swab – Catalog

#HE0053NS
Contains six individually packaged inactivated control swabs containing Methicillin-Resistant
Staphylococcus aureus (MRSA).

Room temperature storage I International restrictions may apply

Methicillin-Susceptible Staphylococcus aureus (MSSA) Inactivated Swab – Catalog

#HE0054NS
Contains six individually packaged inactivated control swabs containing Methicillin-Susceptible
Staphylococcus aureus (MSSA).

Room temperature storage I International restrictions may apply

Methicillin-Susceptible Staphylococcus epidermidis (MSSE) Inactivated Swab –

Catalog #HE0055NS
Contains six individually packaged inactivated control swabs containing Methicillin-Susceptible
Staphylococcus epidermidis (MSSE)

Room temperature storage I International restrictions may apply

BRO19 Rev D Microbiologics Molecular Controls Page 20 of 49

RESPIRATORY PATHOGENS
Cold and flu season is a busy time in the laboratory. QC testing your diagnostic instruments and
assays shouldn’t add to the stress. Microbiologics offers accurate, test-ready controls for a variety of
respiratory pathogens to help you meet laboratory standards and ensure your methods and materials
are producing reliable results.

Page 21 of 47
ASSAY-SPECIFIC PANELS FOR RESPIRATORY TESTING

Cepheid Xpert® Respiratory Control Panel (Inactivated Swab) – Catalog #8199

Contains six pre-pooled positive and six negative, inactivated control swabs (12 swabs/kit) comprised
of the microorganisms listed below. For use with Cepheid Xpert® Xpress Flu/RSV assay.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply
• Not CE Marked

Positive Control (Six swabs/kit):

- Influenza A (H1N1) Virus
- Influenza A (H3H2) Virus
- Influenza B Virus
- Respiratory Syncytial Virus A

Negative Control (Six swabs/kit): Coxsackievirus B1

SYNDROME-SPECIFIC PANELS FOR RESPIRATORY TESTING

Enterovirus (EV) Control Panel (Inactivated Swab)

– Catalog #8190
Contains six positive and six negative, inactivated control
swabs (12 swabs/kit) comprised of the microorganisms
listed below.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six swabs/kit): Coxsackievirus B1

Negative Control (Six swabs/kit): Rhinovirus 1B

Group A Streptococcus (GAS) Control Panel (Inactivated Swab) – Catalog #8219

Contains six positive and six negative, inactivated control swabs (12 swabs/kit) comprised of the
microorganisms listed below.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six swabs/kit): Streptococcus pyogenes

Negative Control (Six swabs/kit): Streptococcus dysgalactiae

BRO19 Rev D Microbiologics Molecular Controls Page 22 of 49

SYNDROME-SPECIFIC PANELS FOR RESPIRATORY TESTING

Respiratory Control Panel (22 Targets)

– Catalog #8247
Contains six pre-pooled positive and six negative, inactivated
microorganism pellets (12 pellets/kit). The negative control
pellets are blank and do not contain organisms.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply
• Not CE Marked

- Adenovirus Type 6 - Influenza A

- Bordetella parapertussis - Influenza A subtype H1
- Bordetella pertussis - Influenza A subtype H1-2009
- Chlamydia pneumoniae - Influenza A subtype H3
- Coronavirus 229E - Influenza B
- Coronavirus HKU1 surrogate - Mycoplasma pneumoniae
- Coronavirus NL63 surrogate - Parainfluenza Virus 1
- Coronavirus OC43 surrogate Strain 1 and - Parainfluenza Virus 2
Coronavirus OC43 surrogate Strain 2 - Parainfluenza Virus 3
- Human Metapneumovirus surrogate - Parainfluenza Virus 4a surrogate
- Human Rhinovirus - Respiratory Syncytial Virus
- SARS-CoV-2 Virus

Respiratory (21 Targets) Control Panel

– Catalog #8217
Contains six pre-pooled positive and six negative, inactivated
microorganism pellets (12 pellets/kit). The negative control
pellets are blank and do not contain organisms.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- Adenovirus Type 6 - Influenza A

- Bordetella parapertussis - Influenza A subtype H1
- Bordetella pertussis - Influenza A subtype H1-2009
- Chlamydia pneumoniae - Influenza A subtype H3
- Coronavirus 229E - Influenza B
- Coronavirus HKU1 surrogate - Mycoplasma pneumoniae
- Coronavirus NL63 surrogate - Parainfluenza Virus 1
- Coronavirus OC43 surrogate Strain 1 and - Parainfluenza Virus 2
Coronavirus OC43 surrogate Strain 2 - Parainfluenza Virus 3
- Human Metapneumovirus surrogate - Parainfluenza Virus 4a surrogate
- Human Rhinovirus - Respiratory Syncytial Virus

BRO19 Rev D Microbiologics Molecular Controls Page 23 of 49

SYNDROME-SPECIFIC PANELS FOR RESPIRATORY TESTING

Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab) - Catalog #8246

Contains six pre-pooled positive and six negative, inactivated control swabs (12 swabs/kit) comprised
of the microorganisms listed below.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six swabs/kit):

- Influenza A (H1N1) Virus
- Influenza A (H3N2) Virus
- Influenza B Virus
- Respiratory Syncytial Virus A
- SARS-CoV-2 Virus
- Human lung epithelial cells

Negative Control (Six swabs/kit):

- Coxsackievirus B1
- Human lung epithelial cells

BRO19 Rev D Microbiologics Molecular Controls Page 24 of 49

SYNDROME-SPECIFIC PANELS FOR RESPIRATORY TESTING

Rifampicin-Resistant Mycobacterium tuberculosis Positive

Control Panel (Inactivated Pellet) – Catalog #8206
Contains six inactivated, pre-pooled microorganism pellets
comprised of the organisms listed below (18 pellets/kit).

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Positive Control 1 (Six pellets/kit):

- Mycobacterium bovis (MTB) (BCG)

Positive Control 2 (Six pellets/kit):

- Mycobacterium tuberculosis (MTB/RIF)
surrogate (rpoB: L511P, H526Y, S531L)

Positive Control 3 (Six pellets/kit):

- Mycobacterium tuberculosis (MTB/RIF)
surrogate (rpoB: D516V, S522L)

Rifampicin-Resistant Mycobacterium
tuberculosis Negative Control
(Inactivated Pellet) – Catalog #8238
Contains six inactivated pellets of Mycobacterium
gordonae (six pellets/kit).

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

BRO19 Rev D Microbiologics Molecular Controls Page 25 of 49

HELIX ELITE™ MOLECULAR STANDARDS FOR RESPIRATORY TESTING

Inactivated Helix Elite Molecular Standards

Full process controls for use in molecular testing.
Each kit contains five unassayed inactivated
microorganism pellets packaged in individual vials
for ease-of-use.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Inactivated Adenovirus 2 – Inactivated Parainfluenza Virus 3 –

Catalog #HE0026N Catalog #HE0033N
- Strain Adenoid 6 - Strain C243

Inactivated Respiratory Syncytial Inactivated Chlamydia pneumoniae –

Virus A – Catalog #HE0028N Catalog #HE0034N
- Strain Long
Inactivated Varicella Zoster Virus –
Inactivated Influenza A (H1N1) Virus Catalog #HE0038N
– Catalog #HE0029N - Strain VZ-10
- Strain subtype H1N1
Inactivated Influenza A (H3N2) Virus –
Inactivated Influenza B Virus – Catalog #HE0043N
Catalog #HE0030N - Strain subtype H3N2
- Strain Hong Kong/5/72

Inactivated Influenza A/B and

Inactivated Parainfluenza Virus 1 – Respiratory Syncytial Virus – Catalog
Catalog #HE0031N #HE0044N
- Strain VP1 Each pellet contains:
- Influenza A (H1N1) Virus

Inactivated Parainfluenza Virus 2 – - Influenza B Virus, Strain Hong Kong/5/72

Catalog #HE0032N - Respiratory Syncytial Virus (RSV) A, Strain Long

- Strain Greer
Inactivated Enterovirus D68 – Catalog
#HE0050N

BRO19 Rev D Microbiologics Molecular Controls Page 26 of 49

HELIX ELITE™ MOLECULAR STANDARDS FOR RESPIRATORY TESTING

Inactivated SARS-CoV-2 Whole Virus (Pellet)

– Catalog #HE0065N
Contains five individually packaged lyophilized pellets
made with whole inactivated SARS-CoV-2 virus
(Isolate SARS-CoV-2/USA/WA1/2020) and inactivated
human lung epithelial cells. Each kit also contains five
vials of molecular standard water for rehydration.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

SARS-CoV-2 Whole Virus can be used to monitor the extraction, amplification and detection of SARS-CoV-2
molecular applications.

Inactivated SARS-CoV-2 Whole Virus (Swab) – Catalog #HE0066NS

Contains six individually packaged lyophilized swabs made with whole
inactivated SARS-CoV-2 virus (Isolate SARS-CoV-2/USA/WA1/2020) and
inactivated human lung epithelial cells.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

SARS-CoV-2 Whole Virus can be used to monitor the extraction, amplification and
detection of SARS-CoV-2 molecular applications.

BRO19 Rev D Microbiologics Molecular Controls Page 27 of 49

SYNTHETIC HELIX ELITE™ MOLECULAR STANDARDS FOR RESPIRATORY TESTING

SARS-CoV-2 Process Control (Pellet)

– Catalog #HE0062S

Contains five individually packaged inactivated

lyophilized pellets made with RNA transcripts
containing diagnostically relevant targets (CDC and
WHO consensus sequences: Orf1ab/RdRP/S/E/ORF8/
M/N) encapsulated in a phage protein and human lung
epithelial cells. See website for positions of each gene
targets. Each kit also contains five vials of molecular
standard water for rehydration.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

SARS-CoV-2 Process Control can be used to monitor the extraction, amplification and detection of SARS-CoV-2
molecular applications

SARS-CoV-2 Process Control (Swab) – Catalog #HE0063S

Contains five individually packaged inactivated lyophilized swabs made with

RNA transcripts containing diagnostically relevant targets (CDC and WHO
consensus sequences: Orf1ab/RdRP/S/E/ORF8/M/N) encapsulated in a
phage protein and human lung epithelial cells. See website for positions of
each gene target.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

SARS-CoV-2 Process Control can be used to monitor the extraction, amplification

and detection of SARS-CoV-2 molecular applications

BRO19 Rev D Microbiologics Molecular Controls Page 28 of 49

SYNTHETIC HELIX ELITE™ MOLECULAR STANDARDS FOR RESPIRATORY TESTING

Synthetic Helix Elite Molecular Standards

For use as a positive control in molecular applications.

Each kit contains one vial of dried synthetic consensus
sequence DNA or RNA (up to 100 reactions), and one
vial of molecular standard water for rehydration.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

SARS-CoV-2 Synthetic RNA (N Gene SARS-CoV-2 Synthetic RNA (N/E/RdRp/S

Targets) – Catalog #HE0060S Gene Targets) – Catalog #HE0061S

Contains one vial of dried synthetic RNA Contains one vial of dried synthetic RNA and one
and one vial of molecular standard water vial of molecular standard water for rehydration.
for rehydration. The SARS-CoV-2 synthetic See website for complete list of targets.
RNA material is a 1044-nucleotide portion
of the SARS-CoV-2 N (nucleocapsid) gene. It
contains three markers N1, N2 and N3 that
are commonly used in diagnostic assays.

BRO19 Rev D Microbiologics Molecular Controls Page 29 of 49

WOMEN’S HEALTH AND STI
Your laboratory is committed to elevating the standard of care for women’s health and sexually
transmitted infections (STIs) with advanced diagnostic technologies. When it comes to QC testing
your rapid diagnostic assays, you should expect the same level of quality. Microbiologics offers a
variety of controls for women’s health and STI testing featuring room temperature storage, pre-
pooling of strains, and formats that mimic patient sample processing for ease of use.

Page 30 of 47
ASSAY-SPECIFIC PANELS FOR WOMEN’S HEALTH AND STI TESTING

BD MAX™ CT/GC/TV 20-Day QC Panel –

Catalog #8193
Contains 20 inactivated, pre-pooled microorganism pellets
each comprised of the organisms recommended by the
manufacturer for QC listed below. For use with BD MAX™
CT/GC/TV assay.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- Chlamydia trachomatis
- Neisseria gonorrhoeae
- Trichomonas vaginalis

Cepheid Xpert® CT/NG Control Panel – Catalog #8188

Contains six pre-pooled positive and six negative, inactivated control swabs (12 swabs/kit)
comprised of the microorganisms listed below. For use with Cepheid Xpert® CT/NG assay.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply
• Not CE Marked

Positive Control (Six swabs/kit):

- Chlamydia trachomatis (LGV-2-434)
- Neisseria gonorrhoeae

Negative Control (Six swabs/kit):

- Human cells
Product image applies to both CAT #8188 and CAT #8194

Cepheid Xpert® GBS LB Control Panel – Catalog #8194

Contains six positive and six negative, inactivated control swabs (12 swabs/kit) comprised of the
microorganisms listed below. For use with Cepheid Xpert® GBS LB assay.
• Room temperature storage
• For in vitro diagnostic use
• International restrictions may apply
• Not CE Marked

Positive Control (Six swabs): Streptococcus agalactiae

Negative Control (Six swabs): Lactobacillus acidophilus

BRO19 Rev D Microbiologics Molecular Controls Page 31 of 49

SYNDROME-SPECIFIC PANELS FOR WOMEN’S HEALTH AND STI TESTING

CT/GC/TV Control Panel (Inactivated Pellet) –

Catalog #8228
Contains six inactivated, pre-pooled pellets comprised of the
microorganisms listed below (six pellets/kit):
• Room temperature storage
• For in vitro diagnostic use
• International restrictions may apply
- Chlamydia trachomatis
- Neisseria gonorrhoeae
- Trichomonas vaginalis

Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG)

Control Panel (Inactivated Swab) – Catalog #8229
Contains six pre-pooled positive and six negative, inactivated
control swabs (12 swabs/kit) comprised of the microorganisms
listed below.
• Room temperature storage
• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six swabs/kit): Negative Control (Six swabs/kit):

- Chlamydia trachomatis - Human cells
- Neisseria gonorrhoeae

GBS Verification Panel (Live Culture) – Catalog #8173

Contains two KWIK-STIKs of each strain listed below (12 KWIK-STIKs total).
- Streptococcus agalactiae (B) derived from ATCC® 12386™*
- Streptococcus agalactiae (B, III) derived from ATCC® 12403™*
- Streptococcus anginosus (G) derived from NCTC 10713
- Streptococcus dysgalactiae subsp. equisimilis (C) derived from ATCC® 12388™*
- Streptococcus pyogenes (A) derived from ATCC® 19615™*
- Streptococcus agalactiae (III) derived from ATCC® BAA-22™*
*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative
Emblem, the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is
licensed to use these trademarks and to sell products derived from ATCC® cultures.

Group B Streptococcus (GBS) Control Panel (Inactivated Swab) – Catalog #8232

Contains six positive and six negative, inactivated control swabs (12 swabs/kit) comprised of the
microorganisms listed below.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply
Positive Control (Six swabs/kit): Streptococcus agalactiae
Negative Control (Six swabs/kit): Lactobacillus acidophilus

BRO19 Rev D Microbiologics Molecular Controls Page 32 of 49

SYNDROME-SPECIFIC PANELS FOR WOMEN’S HEALTH AND STI TESTING

GBS QC Set (Live Culture) – Catalog #8164

Each set contains a low, medium and high level of the same microorganism
and one negative control (Four KWIK-STIKs/kit).

- Low: Streptococcus agalactiae (Group B, lb) derived from ATCC® 12401™*

- Medium: Streptococcus agalactiae (Group B, lb) derived from ATCC® 12401™*
- High: Streptococcus agalactiae (Group B, lb) derived from ATCC® 12401™*
- Negative Control: Lactobacillus acidophilus derived from ATCC® 4356™*

*Look for the ATCC Licensed Derivative® Emblem for all products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem,
the ATCC Licenses Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use
these trademarks and to sell products derived from ATCC® cultures.

Human Papillomavirus (HPV) Verification Panel

– Catalog #8216

Contains 20 inactivated, pre-pooled microorganism

pellets each comprised of the organisms listed below.
Control includes DNA sequences for E6/E7 amplification
of HPV 16, 18 and 45 types.

• Room temperature storage

• For in vitro diagnostic use
• Does not contain human beta globin
• International restrictions may apply
- HPV 16 gene target E6/E7
- HPV 18 gene target E6/E7
- HPV 45 gene target E6/E7

Human Papillomavirus (HPV) Control Panel –

Catalog #8214
Contains six inactivated, pre-pooled microorganism
pellets comprised of the organisms listed below. Control
includes DNA sequences for E6/E7 amplification of HPV
16, 18 and 45 types.

• Room temperature storage

• For in vitro diagnostic use
• Does not contain human beta globin
• International restrictions may apply

- HPV 16 gene target E6/E7

- HPV 18 gene target E6/E7
- HPV 45 gene target E6/E7

BRO19 Rev D Microbiologics Molecular Controls Page 33 of 49

SYNDROME-SPECIFIC PANELS FOR WOMEN’S HEALTH AND STI TESTING

Multi-Strain Human Papillomavirus (HPV) Verification

Panel (Inactivated Pellet) – Catalog #8235
Contains 20 inactivated, pre-pooled pellets comprised of human
cells and the microorganisms listed below (20 pellets/kit):

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- HPV 16 gene target E6/E7 and L1

- HPV 18 gene target E6/E7 and L1
- HPV 31 gene target E6/E7 and L1
- HPV 45 gene target E6/E7 and L1
- HPV 68 gene target E6/E7 and L1
- Human Cells

Multi-Strain Human Papillomavirus (HPV) Control

Panel (Inactivated Pellet) – Catalog #8234
Contains six inactivated, pre-pooled pellets comprised of human
cells and the microorganisms listed below (six pellets/kit):

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

- HPV 16 gene target E6/E7 and L1

- HPV 18 gene target E6/E7 and L1
- HPV 31 gene target E6/E7 and L1
- HPV 45 gene target E6/E7 and L1
- HPV 68 gene target E6/E7 and L1
- Human Cells

Mycoplasma genitalium Control Panel (Inactivated

Pellet) – Catalog #8240
Contains six inactivated, pre-pooled pellets comprised of the
microorganisms listed below each control listed below (12
pellets/kit).

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six pellets/kit):

- Mycoplasma genitalium

Negative Control (Six pellets/kit):

- Blank pellet

BRO19 Rev D Microbiologics Molecular Controls Page 34 of 49

SYNDROME-SPECIFIC PANELS FOR WOMEN’S HEALTH AND STI TESTING

Trichomonas vaginalis (TV) Control Panel (Inactivated Swab) – Catalog #8189

Contains six positive (pre-pooled) and six negative inactivated control swabs (12 swabs/kit)
comprised of the strains listed below.
• Room temperature storage
• For in vitro diagnostic use
• International restrictions may apply

Positive Control (Six swabs/kit):

- Trichomonas vaginalis
- Human cells
Negative Control (Six swabs/kit):
- Neisseria gonorrhoeae
- Human cells

Vaginal Verification Panel – Catalog #8208

Includes two boxes containing 20 individually
packaged inactivated microorganism pellets of
each pool listed below (120 pellets/kit).
• Room temperature storage
• For in vitro diagnostic use
• International restrictions may apply

Pool 1 (20 pellets/kit) Pool 4 (20 pellets/kit) Pool 6 (20 pellets/kit)

- Lactobacillus crispatus - Atopobium vaginae - Atopobium vaginae
- Gardnerella vaginalis - Candida krusei
Pool 2 (20 pellets/kit) - BVAB2 surrogate - Gardnerella vaginalis
- Gardnerella vaginalis - Trichomonas vaginalis - Lactobacillus crispatus
Pool 3 (20 pellets/kit) Pool 5 (20 pellets/kit)
- Atopobium vaginae - Atopobium vaginae
- Candida albicans - Candida glabrata
- Gardnerella vaginalis - Gardnerella vaginalis
- BVAB2 surrogate - Lactobacillus crispatus

Vaginal Control Panel – Catalog #8209

Contains six inactivated, pre-pooled microorganism pellets of each pool listed below (12 pellets/kit).
• Room temperature storage
• For in vitro diagnostic use Pool 1 (Six pellets/kit) Pool 2 (Six pellets/kit)
• International restrictions may apply - Lactobacillus crispatus - Atopobium vaginae
- Candida albicans
- Candida glabrata
- Candida krusei
- Gardnerella vaginalis
- BVAB2 surrogate
- Trichomonas vaginalis

BRO19 Rev D Microbiologics Molecular Controls Page 35 of 49

HELIX ELITE™ MOLECULAR STANDARDS FOR WOMEN’S HEALTH AND STI TESTING

Inactivated Helix Elite Molecular Standards

Full process controls for use in molecular testing. Each kit

contains five unassayed lyophilized pellets packaged in
individual vials for ease-of-use.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Inactivated Chlamydia trachomatis – Inactivated Chlamydia trachomatis/Neisseria

Catalog #HE0035N gonorrhoeae (CT/NG) – Catalog #HE0045N
- Strain LGV-2-434 - Chlamydia trachomatis Strain LGV-2-434
- Neisseria gonorrhoeae Strain GL0071
Inactivated Herpes Simplex Virus 1 –
Catalog #HE0036N Inactivated Herpes Simplex Virus 2 –
- Strain MacIntyre Catalog #HE0037N
- Strain MS
Inactivated Neisseria gonorrhoeae –
Catalog #HE0041N Inactivated Trichomonas vaginalis –
- Strain GL0071 Catalog #HE0042N
- Strain GL0028
Human Papillomavirus 16 (HPV 16)
Human Papillomavirus 18 (HPV 18) Cellularity
Cellularity Control (Inactivated Pellet) –
Control (Inactivated Pellet) – Catalog #HE0057N
Catalog #HE0056N

Synthetic Helix Elite Molecular Standards

For use as a positive control in molecular applications.

Kits contain: one vial of dried synthetic DNA or RNA
(approximately 100 reactions), and one vial of molecular
standard water for rehydration.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply
• Dried DNA Preserved with Biomatrica DNAstable®

Human papillomavirus 16 Synthetic DNA – Catalog #HE0046S

- Fragments of E6,E7 and L1 genes

Human papillomavirus 18 Synthetic DNA – Catalog #HE0048S

- Fragments of E6, E7 and L1 genes

Treponema pallidum Synthetic DNA – Catalog #HE0047S

- Fragments of 47 kDa protein and DNA Polymerase I genes

BRO19 Rev D Microbiologics Molecular Controls Page 36 of 49

EMERGING DISEASES
AND OTHER PATHOGENS
With emerging diseases comes expanded pathogen testing and quality control needs.
Microbiologics provides a variety of controls with features designed to simplify verification and QC
including room temperature storage and pre-pooling of strains. From parasitology to patient/donor
screening and testing, Microbiologics has your control needs covered.

Page 37 of 47
HELIX ELITE™ FOR EMERGING DISEASE AND OTHER PATHOGEN TESTING

Inactivated Helix Elite Molecular Standards

Full process controls for use in molecular testing.
Each kit contains five unassayed lyophilized pellets
packaged in individual vials for ease-of-use.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Inactivated Cytomegalovirus High Control – Catalog #HE0040N

- AD-169

Inactivated Cytomegalovirus Low Control – Catalog #HE0039N

- AD-169

Inactivated Cryptosporidium and Giardia – Catalog #HE0049N

- Giardia lamblia (Strain H3)
- Cryptosporidium parvum (Strain Iowa)

Inactivated Borrelia burgdorferi – Catalog #HE0052N

Synthetic Helix Elite Molecular Standards

For use as a positive control in molecular applications.
Each kit contains one vial of dried synthetic DNA or RNA
(approximately 100 reactions), and one vial of molecular
standard water for rehydration.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Cryptosporidium hominis Synthetic DNA – Catalog #HE0001S

- 18S rRNA gene of Cryptosporidium hominis | Dried DNA Preserved with Biomatrica DNAstable®

Cryptosporidium parvum Synthetic DNA – Catalog #HE0002S

- 18S rRNA gene of Cryptosporidium parvum | Dried DNA Preserved with Biomatrica DNAstable®

Cyclospora cayetanensis Synthetic DNA – Catalog #HE0025S

- 18S rRNA gene of Cyclospora cayentanensis | Dried DNA Preserved with Biomatrica DNAstable®

Dientamoeba fragilis Synthetic DNA – Catalog #HE0015S

- 18S rRNA gene of Dientamoeba fragilis | Dried DNA Preserved with Biomatrica DNAstable®

Eastern Equine Encephalitis Virus Synthetic RNA – Catalog #HE0016S

- Fragments from the NSP3 gene, the capsid protein gene, and the E2 glycoprotein gene | Dried RNA
Preserved with Biomatrica RNAstable® | Export license required for shipping outside U.S.

BRO19 Rev D Microbiologics Molecular Controls Page 38 of 49

HELIX ELITE™ FOR EMERGING DISEASE AND OTHER PATHOGEN TESTING

Synthetic Helix Elite Molecular Standards

For use as a positive control in molecular applications.

Each kit contains one vial of dried synthetic DNA or RNA
(up to 100 reactions), and one vial of molecular standard
water for rehydration.

• Room temperature storage

• For in vitro diagnostic use
• International restrictions may apply

Encephalitozoon intestinalis Synthetic DNA – Catalog #HE0004S

- 18S rRNA gene of Encephalitozoon intestinalis | Dried DNA Preserved with Biomatrica DNAstable®

Entamoeba dispar Synthetic DNA – Catalog #HE0007S

-18S rRNA gene of Entamoeba dispar | Dried DNA Preserved with Biomatrica DNAstable®

Entamoeba histolytica Synthetic DNA – Catalog #HE0006S

- 18S rRNA gene of Entamoeba histolytica | Dried DNA Preserved with Biomatrica DNAstable®

Enterocytozoon bieneusi Synthetic DNA – Catalog #HE0003S

- 18S rRNA gene of Enterocytozoon bieneusi | Dried DNA Preserved with Biomatrica DNAstable®

Giardia lamblia Synthetic DNA – Catalog #HE0005S

- 18S rRNA gene of Giardia lamblia | Dried DNA Preserved with Biomatrica DNAstable®

Plasmodium falciparum Synthetic DNA – Catalog #HE0008S

- 18S rRNA gene of asexual Plasmodium falciparum I Dried DNA Preserved with Biomatrica DNAstable®

Plasmodium ovale Synthetic DNA – Catalog #HE0010S

- 18S rRNA gene of asexual Plasmodium ovale | Dried DNA Preserved with Biomatrica DNAstable®

Plasmodium malariae Synthetic DNA – Catalog #HE0011S

- 18S rRNA A-type gene of Plasmodium malariae | Dried DNA Preserved with Biomatrica DNAstable®

Plasmodium vivax Synthetic DNA – Catalog #HE0009S

- 18S rRNA gene of asexual Plasmodium vivax | Dried DNA Preserved with Biomatrica DNAstable®

West Nile Virus Synthetic RNA – Catalog #HE0014S

- Fragments from the 5’UTR region, anchored capsid protein C gene, capsid protein C gene, membrane
glycoprotein precursor prM gene, envelope protein E gene, nonstructural protein NS1, NS2A, NS3, and
NS5 genes, and the 3’ UTR region of the West Nile Virus genome | Dried RNA Preserved with
Biomatrica RNAstable®

BRO19 Rev D Microbiologics Molecular Controls Page 39 of 49

Helix EliteTM Inactivated Molecular Standards contain multiple targets available for gastrointestinal,
respiratory, sexual health and transplant assays. These controls can be applied to: Sensitivity and
specificity testing, verification and validation, assay optimization, and training. Other applications
include: Proficiency testing, lot-to-lot assay testing, and external assay QC. Inactivated, Full Process
Controls for Molecular Assays

Package Details:
Products contain the following:

• Pellet format contains five • Swab format contains six

qualitative lyophilized individually packaged
microorganism pellets lyophilized swabs and
packaged in individual vials Instructions for Use
and Instructions for Use

Product Highlights:
• Fully intact, non-viable process controls
• Used for every step of the molecular testing process: from extraction through detection
• Quick-dissolve lyophilized pellets and lyophilized swabs may be reconstituted in buffer or transport medium and
processed using the same protocols as the patient sample
• Independent external controls provide accurate, reliable results
• Test-ready format saves you time and money
• Easy and economical room temperature storage
• FDA listed and CE Marked as an In Vitro Diagnostic (IVD) Medical Device
• Technical Support Experts available for guidance

NEGATIVE CELLULARITY CONTROLS

Negative Cellularity Control (Inactivated Pellet) - Catalog #HE0058N

- Human lung epithelial cells

Negative Cellularity Control (Inactivated Swab) - Catalog #HE0067NS

- Human lung epithelial cells

BRO19 Rev D Microbiologics Molecular Controls Page 40 of 49

INACTIVATED HELIX ELITE™
Catalog Full Product
Product Description
Number Details

HE0026N Inactivated Adenovirus 2 See page 26

HE0052N Inactivated Borrelia burgdoferi See page 38

HE0034N Inactivated Chlamydia pneumoniae See page 26

HE0035N Inactivated Chlamydia trachomatis See page 36

HE0045N Inactivated Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) See page 36

HE0049N Inactivated Cryptosporidium and Giarda See page 38

HE0040N Inactivated Cytomegalovirus High Control See page 38

HE0039N Inactivated Cytomegalovirus Low Control See page 38

HE0050N Inactivated Enterovirus D68 See page 26

HE0036N Inactivated Herpes Simplex Virus 1 See page 36

HE0037N Inactivated Herpes Simplex Virus 2 See page 36

HE0056N Inactivated Human Papillomavirus 16 (HPV) Cellularity Control See page 36

HE0057N Inactivated Human Papillomavirus 18 (HPV) Cellularity Control See page 36

HE0044N Inactivated Influenza A/B and Respiratory Syncytial Virus See page 26

HE0029N Inactivated Influenza A (H1N1) Virus See page 26

HE0043N Inactivated Influenza A (H3N2) Virus See page 26

HE0030N Inactivated Influenza B Virus See page 26

HE0041N Inactivated Neisseria gonorrhoeae See page 36

HE0031N Inactivated Parainfluenza Virus 1 See page 26

HE0032N Inactivated Parainfluenza Virus 2 See page 26

HE0033N Inactivated Parainfluenza Virus 3 See page 26

HE0028N Inactivated Respiratory Syncytial Virus A See page 26

HE0027N Inactivated Rotavirus See page 15

HE0065N Inactivated SARS-CoV-2 Whole Virus (Pellet) See page 27

HE0066NS Inactivated SARS-CoV-2 Whole Virus (Swab) See Page 27

BRO19 Rev D Microbiologics Molecular Controls Page 41 of 49

INACTIVATED HELIX ELITE™ CONTINUED
Catalog Full Product
Product Description
Number Details

HE0042N Inactivated Trichomonas vaginalis See page 36

HE0038N Inactivated Varicella Zoster Virus See page 26

Methicillin-Resistant Staphylococcus aureus (MRSA) Inactivated

HE0053NS See page 20
Swab

Methicillin-Susceptible Staphylococcus aureus (MSSA) Inactivated

HE0054NS See page 20
Swab

Methicillin-Susceptible Staphylococcus epidermidis (MSSE)

HE0055NS See page 20
Inactivated Swab

HE0058N Negative Cellularity Control (Inactivated Pellet) See page 40

HE0067NS Negative Cellularity Control (Inactivated Swab) See page 40

BRO19 Rev D Microbiologics Molecular Controls Page 42 of 49

Helix EliteTM Synthetic Molecular Standards can be applied to a number of test and applications
including but not limited to: Sensitivity and specificity testing, verification and validation, assay
optimization, training, proficiency testing, and lot-to-lot assay testing. Synthetic Nucleic Acid RNA
and DNA Sequences for Use as Amplification and Detection Controls in Molecular Assays.

Package Details:

Products contain the following:

• One vial of dried, stabilized RNA or DNA (up to 100
reactions)

• One vial of molecular standard water for rehydration

• Instructions for Use

Product Highlights:
• Non-hazardous positive controls for molecular diagnostic assays
• Contains consensus sequences of diagnostic regions from the target’s genome, representing the
known genetic diversity of the microorganism
• Compatible with a variety of instruments, kits and applications
• Independent external controls provide accurate, reliable results
• Convenient test ready format saves time and money
• Room temperature storage is easy and economical
• FDA listed and CE Marked as an In Vitro Diagnostic (IVD) Medical Device
• Technical Support Experts available for guidance

BRO19 Rev D Microbiologics Molecular Controls Page 43 of 49

SYNTHETIC HELIX ELITE™
Catalog Full Product
Product Description
Number Details

HE0001S Cryptosporidium hominis Synthetic DNA See page 38

HE0002S Cryptosporidium parvum Synthetic DNA See page 38

HE0025S Cyclospora cayetanensis Synthetic DNA See page 38

HE0015S Dientamoeba fragilis Synthetic DNA See page 38

HE0016S Eastern Equine Encephalitis Virus Synthetic RNA See page 38

HE0004S Encephalitozoon intestinalis Synthetic DNA See page 39

HE0007S Entamoeba dispar Synthetic DNA See page 39

HE0006S Entamoeba histolytica Synthetic DNA See page 39

HE0003S Enterocytozoon bieneusi Synthetic DNA See page 39

HE0005S Giardia lamblia Synthetic DNA See page 39

HE0046S Human papillomavirus 16 Synthetic DNA See page 36

HE0048S Human papillomavirus 18 Synthetic DNA See page 36

HE0013S Norovirus GI.1 Synthetic RNA See page 15

HE0012S Norovirus GII.4 Synthetic RNA See page 15

HE0008S Plasmodium falciparum Synthetic DNA See page 39

HE0011S Plasmodium malariae Synthetic DNA See page 39

HE0010S Plasmodium ovale Synthetic DNA See page 39

HE0009S Plasmodium vivax Synthetic DNA See page 39

HE0060S SARS-CoV-2 Synthetic RNA (N Gene Targets) See page 29

HE0061S SARS-CoV-2 Synthetic RNA (N/E/RdRp/S Gene Targets) See page 29

HE0062S SARS-CoV-2 Process Control (Pellet) See page 28

HE0063S SARS-CoV-2 Process Control (Swab) See page 28

HE0047S Treponema pallidum Synthetic DNA See page 36

HE0014S West Nile Virus Synthetic RNA See page 39

BRO19 Rev D Microbiologics Molecular Controls Page 44 of 49

QC SETS AND PANELS
Microbiologics QC Sets and Panels offer QC of microbial identification for detection instruments
and commercial diagnostic assays including biochemical, PCR, and molecular technologies.
Microbiologics QC Sets and Panels can be applied to verification, validation and routine quality
control testing. Bundled Sets and Panels of Microorganism Strains for QC and Verification of Assays
and Test Kits.

Package Details:
• Live Culture QC Sets and Panels

• Inactivated Microorganism QC Sets and Panels

• Synthetic DNA/RNA QC Sets and Panels

Product Highlights:
• Each assay-specific QC set or panel contains the manufacturer recommended quality control
strains for a particular assay in an easy-to-use format
• Each syndrome-specific QC set or panel contains common quality control strains for syndromic
assays in an easy-to-use format
• One simple catalog number for fast, easy ordering
• Protects your reputation by providing documentation and assurance that the laboratory can
consistently produce accurate results
• Ensures testing procedures and materials are working properly
• Convenient, test-ready format saves time and money
• Technical Support Experts available for guidance

BRO19 Rev D Microbiologics Molecular Controls Page 45 of 49

ASSAY-SPECIFIC QC SETS AND PANELS
Catalog Full Product
Product Description
Number Details

8193 BD MAX™ CT/GC/TV 20-Day QC Panel See page 31

8202 BD MAX™ Enteric Parasite 20-Day QC Panel See page 10

8204 BD MAX™ Enteric Parasite Control Panel See page 10

8200 Cepheid Xpert® C. difficile/Epi Control Panel (Inactivated Swab) See page 17

8188 Cepheid Xpert® CT/NG Control Panel (Inactivated Swab) See page 31

8194 Cepheid Xpert® GBS LB Control Panel (Inactivated Swab) See page 31

Cepheid Xpert® MRSA NxG Control Panel

8195 See page 17
(Inactivated Swab)

8196 Cepheid Xpert® Nasal Control Panel (Inactivated Swab) See page 17

8199 Cepheid Xpert® Respiratory Control Panel (Inactivated Swab) See page 22

BRO19 Rev D Microbiologics Molecular Controls Page 46 of 49

SYNDROME-SPECIFIC QC SETS AND PANELS
Catalog Full Product
Product Description
Number Details

8215 Blood Culture Identification (BCID) Control Panel (Inactivated) See page 4

8201 Blood Culture Identification (BCID) Verification Panel (Inactivated) See page 4

5229P Blood Culture Identification (BCID) Verification Panel (Live Culture) See page 5

5258P Blood Culture Identification 2 (BCID2) Verification Panel (Live Culture) See page 6

8227 C. difficile Control Panel (Inactivated Swab) See page 18

8171 C. difficile QC Set (Live Culture) See page 18

8243 C. difficile Verification Panel (Live Culture) See page 18

Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel

8187 See page 19
(Inactivated Swab)

Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel

8229 See page 32
(Inactivated Swab)

8228 CT/GC/TV Control Panel (Inactivated Pellet) See page 32

8231 Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet) See page 13

8179 Enteric Bacterial Organism Set (Live Culture) See page 11

8230 Enteric Parasite Control Panel (Inactivated Pellet) See page 11

8182 Enteric Parasite Verification Panel (Synthetic) See page 11

8184 Enteric Pathogens Control Panel (Inactivated Pellet) See page 12

8211 Enteric Viral Control Panel See page 12

8210 Enteric Viral Verification Panel See page 12

8190 Enterovirus (EV) Control Panel (Inactivated Swab) See page 22

8191 Extended Enteric Bacterial Verification Panel (Inactivated Pellet) See page 13

8246 Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab) See page 24

8236 Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet) See page 14

8219 Group A Streptococcus (GAS) Control Panel (Inactivated Swab) See page 22

8232 Group B Streptococcus (GBS) Control Panel (Inactivated Swab) See page 32

8164 GBS QC Set (Live Culture) See page 33

BRO19 Rev D Microbiologics Molecular Controls Page 47 of 49

SYNDROME-SPECIFIC QC SETS AND PANELS CONTINUED
Catalog Full Product
Product Description
Number Details

8181 Gram-Negative Blood Culture Control Panel (Inactivated Pellet) See page 8

5226P Gram-Negative Blood Culture Control Panel (Live Culture) See page 8

8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet) See page 7

5225P Gram-Positive Blood Culture Control Panel (Live Culture) See page 7

8214 Human Papillomavirus (HPV) Control Panel See page 33

8216 Human Papillomavirus (HPV) Verification Panel See page 33

8174 MRSA Organism Set (Live Culture) See page 19

Multi-Strain Human Papillomavirus (HPV) Control Panel

8234 See page 34
(Inactivated Pellet)

Multi-Strain Human Papillomavirus (HPV) Verification Panel

8235 See page 34
(Inactivated Pellet)

8240 Mycoplasma genitalium Control Panel (Inactivated Pellet) See page 34

8205 Norovirus Control Panel (Inactivated Swab) See page 14

8178 SA Organism Set (Live Culture) See page 19

Live Culture Staphylococcus Controls See page 20

8247 Respiratory Control Panel (22 Targets) See page 23

8217 Respiratory (21 Targets) Control Panel See page 23

Rifampicin-Resistant Mycobacterium tuberculosis Negative Control

8238 See page 25
(Inactivated Pellet)

Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel

8206 See page 25
(Inactivated Pellet)

8173 GBS Verification Panel (Live Culture) See page 32

8189 Trichomonas vaginalis (TV) Control Panel (Inactivated Swab) See page 35

8209 Vaginal Control Panel See page 35

8208 Vaginal Verification Panel See page 35

8203 Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab) See page 20

BRO19 Rev D Microbiologics Molecular Controls Page 48 of 49

PAYMENT AND SHIPPING
PAYMENT OPTIONS
Microbiologics accepts payment by the following methods:
• ACH
• Check (payable to Microbiologics, Inc.)
• Credit card
• Money order
• Wire transfer

Important: To ensure your payment is processed accurately, please note your account number and the invoice
number on all correspondence and payments.

Credit Card Purchases

Microbiologics welcomes the use of VISA®, MasterCard® and American Express®.

Terms
• All invoices are payable “Net 30 Days” (with the exception of credit card payments)
• Past due accounts are subject to finance charges of 1.5% per month
• All payments are paid in United States Dollars (USD)
• A royalty fee will be charged on behalf of the culture collection.
• If not reflected on an invoice, the purchaser is responsible for all applicable State Sales and Use Taxes
• When paying by wire transfer the customer is responsible to pay all applicable transfer fees. Please email
Microbiologics Customer Service at [email protected] to review options for wire transfer fee payments.

SHIPPING AND DELIVERY

Orders are shipped within 48 hours except when a specific shipping date is requested. All shipments are EXW (Ex
Works) Saint Cloud, Minnesota, unless prior arrangements are made. Lyophilized microorganisms are identified as
Biological Substance Category B or Infectious Substance and are subject to regulated packaging materials, special
labeling and special shipping requirements. All shipping and handling charges will be listed as separate line items
on the invoice.

Products are shipped at ambient temperature unless otherwise requested. The outside of the shipping container
is identified with the notation “refrigerate upon receipt” to assure proper handling and storage upon arrival. Due
to the nature of our products, we are unable to accept returns. If any product arrives in a damaged condition, the
carrier must note the condition on the delivery receipt. All claims for products damaged during shipment must be
made within 30 days of receipt. Microbiologics guarantees the performance of our products at all times. If at any
time you are dissatisfied with our products or service, please contact our Customer Service team at 1.320.253.1640
or [email protected] for resolution.

TRADEMARKS
Microbiologics® Trademarks: Helix Elite™ is a trademark of Microbiologics, Inc. Microbiologics® is a registered
trademark of Microbiologics, Inc.

BRO19 Rev D Microbiologics Molecular Controls Page 49 of 49

 Microbiologics St. Cloud
200 Cooper Ave N

St. Cloud, MN 56303

+1.320.253.1640 | 1.800.599.2847

[email protected] | microbiologics.com

Microbiologics Lexington Microbiologics Kalamazoo Microbiologics San Diego

1040 Manchester Street WMed Innovation Center 6725 Mesa Ridge Road, Suite 140

Lexington, KY 40508 4717 Campus Drive Center San Diego, CA 92121 USA

Kalamazoo, MI 49008