Document No.

BT-MSDS422

MATERIAL SAFETY DATA SHEET Rev. No. 00

Rev. Date 2016. 03. 25

I. General Information
A. Product Name/Catalogue Number
: AFIAS AFP/ SMFP-27
B. Recommended use of the chemical and restriction on use
Recommended use: In vitro diagnostic Medical Device
Restriction on use: For in vitro diagnostic use only.
C. Manufacturer
: Boditech Med Inc.
D. Address
: 43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gangwon-do, Korea
E. Emergency Phone No.
: +82-33-243-1400

II. Hazard Identification

GHS classification of the product and national or regional

Cartridge Detection buffer

GHS classification Not applicable Not applicable

IMDG Code Not applicable Not applicable

GHS label elements including precautionary

Cartridge Detection buffer

Symbols No data available No data available

Signal word No data available No data available

Hazard statements No data available No data available

Precautionary statements

Cartridge Detection buffer

Prevention No data available No data available

Reaction No data available No data available

Storage No data available No data available

Disposal No data available No data available

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Other hazards

Cartridge
Detection buffer
Test strip Housing

Health: 1

No data
NEPA Flammability: 1 No data available
available

Physical hazard: 0

III. Composition/Information on Ingredients

[Cartridge]

Component Synonyms Classification No. Amount

Test line
No data available No data available 1.03 ± 0.1 ug
: Mouse monoclonal anti-AFP
Test strip
Control line
No data available No data available 0.47 ± 0.04 ug
: Rabbit IgG

Poly(methyl methacrylate) PMMA 9011-14-7 55 ~ 70

Housing
Acrylonitrile butadiene styrene ABS 9003-56-9 28 ~ 45

[Buffer]

Component Synonyms Classification No. Amount

Water Dihydrogen Oxide 7732-18-5

Mouse monoclonal anti-

Fluorescence conjugate No data available 0.18 ± 0.01 ug
AFP

IV. First Aid Measures

- In case of eye contact
: Remove from source of exposure. Wash with copious amounts of water for at least 15 minutes. If irritation or signs
of toxicity occur, seek medical attention.
- In case of skin contact
: Remove from source of exposure. Wash affected area with soap and water. If irritation or signs of toxicity occur,
seek medical attention.
- If inhaled
: Get medical attention immediately. Remove to fresh air. If not breathe, give cardiopulmonary resuscitation. If

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breathing is difficult, give oxygen and continue to monitoring

- If swallowed
: If irritation or signs of toxicity occur, seek medical attention.
* The following symptoms may occur: Irreversible eye damage.
* Medical conditions aggravated by exposure: Pre-existing eye ailments. Hypersensitivity.
* This material should be considered as being potentially infectious.

V. Fire Fighting Measures

- Recommended extinguishing media
: Suitable extinguishing agents including CO2, WATER SPRAY or regular form.
- Specific hazard from the chemical
: Non-flammable, Corrosive or toxic gases and fume may be occurred in fire-emergency. Inhalation may be harmful.
- Special measure for fire-fighters
: Rescuers need to note the personal protective equipment. If not danger, remove containers. Non-flammable, Corrosive
or toxic gases and fume may be occurred in fire-emergency. Inhalation may be harmful.
- Protective Equipment and precautions for Fire fighters
: Chemical resisted protective equipment for fire-fighter.

VI. Accidential Release Measures

- Personal precautions
* If not danger, stop to leak
* Do not contact with exposed material without protective equipment
* Note the avoid conditions and materials
* Do not breathe dust / fume / gas / mist / vapours / spray
- Environmental precautions
: No data available
- Methods and materials for purification and cleaning up
: After absorbed exposed materials, clean up with cleaner and water

VII. Handling and Storage

- Precaution for safe handling
* Avoid skin friction.
* Note the avoid conditions and materials from fire or flame.
* Protective equipment: Chemical resisted protective goggles, gloves, clothes and mask
- Method for safe handling
* Note the avoid conditions and materials.
* Store container tightly closed in a well-ventilated area.
* Storage temperature: low temperature

VIII. Exposure controls and Personal protection

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- Engineering management
: Good insolation and ventilation should be sufficient to control airborne levels.
- Personal protective equipment
Respiratory protection Chemical resisted respiratory protection
Hand protection Chemical resisted protective gloves
Eye protection Chemical resisted eye protection
Skin and body protection Chemical resisted protective clothes

- Standard of exposure
Chemical No data available
Biological No data available

IX. Physical and Chemical properties

Cartridge Detection buffer

Test strip Housing

State Natural color or pigment Liquid at 20 ℃
No data available
processed color

Odor Odorless Little odorless No data available

Odor threshold value No data available No data available No data available

pH No data available Natural 7.83

Melting/ 180 ~ 200°C/

No data available No data available
Freezing point No data available
Initial boiling point or
No data available No data available No data available
boiling range
No flash occurred under No flash occurred under
Flash point No data available
90 ℃ (Closed-cup) 90 ℃ (Closed-cup)

Evaporating rate No data available No data available No data available

Lower explosion limit No data available No data available No data available

Upper explosion limit No data available No data available No data available

Vapor pressure No data available No data available No data available

Not soluble in water,

Water solubility No data available No data available
soluble in acetone

Density No data available 1.11 No data available

Vapor density No data available No data available No data available

No data available No data available

Specific gravity 1.01 (water=1)
(water=1) (water=1)

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N-octan/water partition
No data available No data available No data available
coefficient

Auto-ignition temperature No data available No data available No data available

Decomposition
No data available No data available No data available
temperature

Viscosity No data available No data available No data available

Molecular weight No data available 50,000 ~ 250,000 No data available

X. Stability and Reactivity

Cartridge
Detection buffer
Test strip Housing

- Irritation or toxic gases - Irritation or toxic gases

and fume may be occurred - Stable at high and fume may be occurred
Chemical stability
in fire-emergency temperature and pressure in fire-emergency
- Inhalation may harmful - Inhalation may harmful
Heat, high temperature
Conditions to avoid Heat, high temperature Heat, high temperature
above 200°C
Oxidizing agent: fire or
Materials to avoid No data available No data available
explosive risk
Hazardous decomposition
products formed under fire Irritation or toxic gases and fume may be occurred in fire-emergency
conditions

XI. Toxicological Information

Cartridge Detection buffer

Information on the likely routes of exposure No data available No data available

Acute toxicity No data available No data available

Skin corrosion/Irritation No data available No data available

Serious eye damage/Eye irritation No data available No data available

Respiratory/Skin sensitization No data available No data available

Germ cell mutagenicity No data available No data available

Carcinogenicity No data available No data available

Reproductive toxicity No data available No data available

Specific target organ toxicity(single exposure) No data available No data available

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Specific target organ toxicity(repeated exposure) No data available No data available

Aspiration hazard No data available No data available

XII. Ecological Information

Cartridge Detection buffer

Toxicity No data available No data available

Persistence and degradability No data available No data available

Bio-accumulative potential No data available No data available

Mobility in soil No data available No data available

Other adverse effects No data available No data available

XIII. Disposal Considerations

Test strip Not available

Cartridge
Housing Consider the notice on Waste management act

Detection buffer Not available

XIV. Transport Information

IMDG Code No data available

DRF No data available

RID No data available

ADR No data available

AND No data available

IATA Non-Hazardous for Air Transport

XV. Regulatory Information

Korea Industrial Safety and Health Act No data available

Korea Hazardous Materials Safety Control Act No data available

Korea Toxic Chemical Control Act No data available

Korea Wastes Control Act No data available

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MATERIAL SAFETY DATA SHEET Rev. No. 00

Rev. Date 2016. 03. 25

Other internal and foreign acts No data available

XVI. Other Notes

Limitations: The information and recommendations set forth in this MSDS are believed to be correct as of this date.

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