Ifu Reagent-Kit Ver-25may2022

Reagent kit  Instructions for use 
REF: RLA700
Intended purpose
The device is a consumable, which is used for performing the basophil histamine release assay (BHRA).
The RLA700 reagent kit consists of reagents for the test completion of the BHRA methods that involves
fluorometric detection of histamine.
For in vitro diagnostic use.
Intended user
Reagent kit is for professional (health care) use only.
Composition
Product name Article no UDI code Volume Amount

Wash buffer RLR007W.200 05744003280179 200 mL 1
OPA disc , 5 mg RLR013 05744003280186 10 discs 1
Diluent RLR009 05744003280223 10 mL 10
Stop reagent RLR011 05744003280247 100 mL 1
Tweezer 1
Coupling reagent label 10
Storage and handling conditions

Store at +2 - +8 °C
The reagent must reach room temperature before use.
Material & Equipment required but not provided

Standard laboratory material & equipment
Distilled H2O
Incubator (37 °C)
Plate washer or multi-channel pipette
HistareaderTM501 or HistareaderTM501-1
Reagent preparation
Allow the reagents to reach room temperature before use. Prepare Coupling Reagent during tempering.
Use the tweezer for transfer of OPA disc(s) into the diluent vial(s).
Article Amount Article Amount

RLR013 (OPA disc) 1 disc + RLR009 (diluent) 1 vial (10 mL)
Soak for 60 min & mix by gentle inverting.
Note: The enclosed disc is coated with o-pfthaldialdehyde. The disc is not designed to dissolve into the
diluent.
Label Note date/time on the label provided and affix to vial(s)
Stability Coupling reagent is stable for 8 hrs from preparation
Pool vials It is recommended to pool coupling reagent vials in a suitable beaker
Page 1 (4) ver. 25MAY2022
REF: RLA700
No. of test 1 vial (10 mL) of coupling reagent is sufficient for one BHRA (96-well) plate/panel
Test procedure
1. Pipet 150 µL wash buffer into each well.

2. Incubate for 30-45 min at 37 °C (36-38 °C).
3. Tap the wash buffer out (into waste / sink)
4. Wash the plate with distilled water 3 times. If washing manually (multi-channel pipette) gently tap
the plate upside down after each wash.
5. Gently tap the plate free of any residual water on highly absorbent paper towel after finishing the
washing procedure.
6. Pipet 75 µL coupling reagent into each well.
7. Reaction time: 10 min
NOTE: it is important to time the reaction precisely.
8. Pipet 75 µL stop reagent into each well.
9. Follow separate IFU for fluorometric detection in the HistareaderTM 501/501-1
Test principle
Refer to separately provided BHRA / HR-Test method-specific work instructions.
Warnings
OPA disc, 5 mg - RLR013
DANGER
Contains o-phthaldialdehyde:
H301: Toxic if swallowed.
H314: Causes severe skin burns and eye damage.
H317: May cause an allergic skin reaction.
H335: May cause respiratory irritation.
H410: Very toxic to aquatic life with long lasting effects.
P260: Do not breathe dusts or mists.
P273: Avoid release to the environment.
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
P304+P340+P310: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call
a POISON CENTER/doctor.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.

REF: RLA700
Prepared coupling reagent
The coupling reagent is an environmentally hazardous reagent (See waste disposal information below)
Wash buffer - RLR007W.200

The wash buffer is a non-hazardous reagent.
Diluent - RLR009
The diluent is a non-hazardous reagent.
Stop reagent - RLR011

The stop reagent is a non-hazardous reagent.
Waste disposal
OPA disc, 5 mg - RLR013
The mixture is to be considered as hazardous waste. Disposal should be according to local, state or national
legislation. Dispose of through authority facilities or pass to chemical disposal company.
EWC-code: 16 05 08 (mixture itself)
15 02 02 (paper towel, inert material etc. contaminated with the mixture)
Prepared coupling reagent

The mixture is to be considered as hazardous waste. Disposal should be according to local, state or national
legislation. Dispose of through authority facilities or pass to chemical disposal company.
EWC-code: 16 05 08 (mixture itself)
15 02 02 (paper towel, inert material etc. contaminated with the mixture)
Wash buffer - RLR007W.200

Non-hazardous waste.
Diluent - RLR009
Stop reagent - RLR011

Manufacturer
RefLab ApS
Copenhagen Bioscience Park ‘COBIS’
Ole Maaloes Vej 3
DK 2200 Copenhagen N
Denmark

REF: RLA700
Symbols
CE mark
For in vitro diagnostic use
Catalog number
Batch code
GTIN code
Date of manufacture
Expiry date
Storage temperature
Tests
Consult instructions for use
Manufacturer

Ifu Reagent-Kit Ver-25may2022

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Reagent kit  Instructions for use 

For in vitro diagnostic use.

Product name Article no UDI code Volume Amount

Storage and handling conditions

Material & Equipment required but not provided

Article Amount Article Amount

1. Pipet 150 µL wash buffer into each well.

Page 2 (4) ver. 25MAY2022

Wash buffer - RLR007W.200

Stop reagent - RLR011

Prepared coupling reagent

Wash buffer - RLR007W.200

Stop reagent - RLR011

Page 3 (4) ver. 25MAY2022

For in vitro diagnostic use

Consult instructions for use

Page 4 (4) ver. 25MAY2022

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