Security Classification: Secret Z-105-002502-00-01－2.

MATERIAL SAFETY DATA SHEET

1 Identification of the substance and the company
Product name Total Prostate Specific Antigen（CLIA）
Molecular formula /
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan,
Manufacturer
Shenzhen, P.R. China, 518057
Tel:+86 755 26582888/ Fax:+86 755 26582680
In vitro quantitative determination of total prostate specific antigen (total PSA,
Intended use
TPSA) in human serum or plasma.

2 Hazards
Hazard designation Not available
May cause sensitization by skin contact.. After contact with skin, wash
Health hazards
immediately with plenty of soap and water. Wear suitable gloves.
Pathways Direct contact
Environmental hazards Not available
Explosive hazards Not available

3 Composition / information on ingredients

Pure/Mixture Mixture
Ra: Paramagnetic microparticles coated with monoclonal anti-PSA antibody
(mouse) in TRIS buffer with preservative
Composition
Rb: Monoclonal anti-PSA antibody (mouse)-alkaline phosphatase conjugate in
PBS buffer with preservative
Appearance and Ra: brown suspensions with solid particles
properties Rb: clear and transparent liquids
Hazardous ingredients
Name Concentration CAS NO.
/ / /

4 First-aid measures
If this chemical contacts the skin, remove contaminated clothing; flush the
contact area with plenty of soap and water. Then threat skin with 75% alcohol
Skin contact or benzalkonium bromide.
Where there is evidence of skin sensitization, get medical attention.
Immediately flush eye(s) with plenty of water for at least 15 minutes,
Eye contact occasionally lifting the lower and upper lids. Get medical attention
immediately.
Timely medical treatment. Do not give anything by mouth to an unconscious
Ingestion
person. Do not induce vomiting unless directed by medical personnel.
If breathing becomes difficult, remove victim to fresh air. Seek medical
Inhalation
assistance immediately.

5 Fire-fighting measures

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 Security Classification: Secret Z-105-002502-00-01－2.0

Hazardous
Not inflammable
characteristics
Hazardous combustion
Not available
products
Extinguishing method Use fire extinguishing media appropriate for site conditions.
Fire fighters should wear self-contained breathing apparatus (SCBA) in
Points for attention
confined spaces.

6 Accidental release measures

Personal precautions
Environmental
precautions
Methods for cleaning up
Wear gloves and laboratory coat. Prevent skin and eye contacting.
Prevent the products from entering into sewers, surface- and ground-water and
soil directly.
Use of absorbent material which should be disposed of in a dustbin. Sterilize
with high pressure steam and then throw it away.

7 Handling and storage

Information for safe
Provide adequate ventilation. Avoid generating vapours.
handling
To maintain efficacy, store according to the instructions in the product
Storage
labeling.

8 Exposure controls / personal protection

Exposure limits None established
No special engineering controls are required. Use with good general
Engineering control
ventilation.
Respiratory protection Wear a mask
Under normal conditions, the use of this product should not require respiratory
Eye protection protection. In special circumstances, the use of protection should be evaluated
by authorized institution.
Body protection Lab coats
Hand protection Wear protection gloves
In other special circumstances, the use of protection should be evaluated by
Other protection
authorized institution

9 Physicochemical properties
Appearance and Ra: brown suspensions with solid particles
properties Rb: clear and transparent liquid
Ra: pH 7.0-8.0
PH value
Rb: pH 6.2-7.2
Melting point/Freezing
Not available
point
Boiling point/Initial
Boiling Point/Boiling Not available
range
Density /Relative density Not available
Vapour pressure Not available
Vapour density Not available
Octanol/water partition
Not available
coefficient
Flash point Not applicable
Ignition temperature Not available

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 Security Classification: Secret Z-105-002502-00-01－2.0

(Autoignition
temperature)
Decomposition
Not available
temperature
Combustion/Explosion
Not available
upper limit
Combustion/Explosion
Not available
lower limit
Paramagnetic microparticles : unsolvable
Solubility: in water
Others: soluble

10 Stability and reactivity

Stability
Conditions to avoid
Materials to avoid
Hazardous
decomposition products
Stable in normal conditions.
Frozen, high temperature , light
Not available
Not available

11 Toxicological information
Acute toxicity Not available
Irritation or corrosion to
May cause skin irritation
the skin
Irritation or corrosion to
May cause eye irritation
the eye
Respiration or skin
May cause skin sensitization
sensitization
May cause allergies of mouse, tongue, shield, pharynx and stomach; may
Ingestion
cause nausea, stomach pain, vomiting and diarrhea.
Mutagencity of germ
Not available
cell
Carcinogenicity Not available
Reproductive toxicity Not available
Specific target cell
system toxicity- Not available
throwaway exposure
Specific target cell
system toxicity-repeated Not available
exposure
Inhalation May cause respiratory tract irritation.

12 Ecological information
Ecotoxicity Not available
Persistence/degradability Not available
Bioaccumulation
Not available
potential
Mobility in soil Not available

13 Disposal considerations
Waste product’s
Residual liquid wastes, contaminated containers and packaging.
characterization
Disposal method of Dispose waste product, unused product and contaminated packaging as
waste product infective materials, in accordance with local regulations and guidelines.

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 Security Classification: Secret Z-105-002502-00-01－2.0

Abandoned precaution
Prohibit discharging into environment directly
of waste product

14 Transport information
This substance is not dangerous under current provisions of the Code of
Transport/further International Carriage of Dangerous Goods by Road(ADR）and by Rail(RID),
information of the International Maritime Dangerous Goods Code(IMDG),and of the
International Air Transport Association(IATA) regulations.

15 Regulations
Provisions of safety and applicable chemical in work place (Issued by Labor Ministry (1996) No.423)
Regulations on the control over safety of dangerous chemicals (State Council Order No.344)
Safety data sheet for chemical products content and order of section (GB16483-2008)
Manage rules for manuals, labels and package marks of medical devices (Bureau Order No.10)
List of dangerous goods (GB12268-2005)
Classification and code of dangerous goods (GB6944-2005)
Classification and labels of dangerous chemical substances commonly used (GB13690-2009)
General rules for preparation of precautionary label for chemical (GB15258-2009)
Occupational exposure limits for hazardous agents in the workplace (GBZ 2.1-2007 GBZ 2.2-2007)

16 Other information
Date 2013-11-15

Prepared by Mindray Co. Ltd, IVD BU, Immunoassay Reagent R&D Division
The information herein is believed to be correct as of the date hereof but is provided without warranty of
any kind. The recipient of our product is responsible for ensuring that, where applicable, existing laws and
guidelines are observed.

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