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MATERIAL SAFETY DATA SHEET
1. IDENTIFICATION OF THE PRODUCT AND COMPANY
1.1. Product name / Code : APC Resistance Kit ~120 T REF 5344510
APC Control Kit 2x1 ml REF 5344512
1.2. Recommended use : In-vitro diagnostic test kit
1.3. Manufacturer : Technoclone GmbH
Brunnerstr. 59/5
A-1235 Vienna / AUSTRIA
Tel. + 43 1 86373 - 0
Fax + 43 1 86373 - 44
1.4. Emergency Phone : +43 1 86373 -10
2. COMPOSITION AND INFORMATION ON INGREDIENTS
2.1. Chemical characterization : APC Resistance Kit ~120 T REF 5344510
The kit consists of 5 reagents
Appearance Physical
Reagent Label Composition Odor pH
Color state
APC/RVV-V (+APC) APC, RVV-V, Polybrene, Hepes,
R1 white lyophilisate None 7.4-7.6
Reagent BSA
R2 RVV-V (-APC) Reagent RVV-V, Polyberen Hepes, BSA white lyophilisate None 7.4-7.6
Prothrombin Activator, EDTA.
R3 PTA Reagent white lyophilisate None 7.4-7.6
Hepes, BSA
R4 Dilution Plasma Human Plasma, processed beige lyophilisate None 7.4-7.6
Pooled normal human plasma from
C1 FV-L Negative Control beige lyophilisate None 7.4-7.6*
wild-type blood donors, processed
FV-L Heterozygous Pooled normal human plasma from
C2 beige lyophilisate None 7.4-7.6*
Control wild-type blood donors, processed
* after reconstitution with deionized water
All reagents are lyophilized mixtures of several general purpose and analyte specific reagents to be
reconstituted with deionized water. Except for the hazardous ingredients described under 2.2. none of
the ingredients are classified as dangerous acc. to the European Community Directive 93/112/EC
amended 91/155/EC.
APC Control Kit 2x1 ml REF 5344512
The kit consists of 2 control reagents
Appearance Physical
Reagent Label Composition Odor pH
Color state
Pooled normal human plasma from
C1 FV-L Negative Control beige lyophilisate None 7.4-7.6*
wild-type blood donors, processed
FV-L Heterozygous Pooled normal human plasma from
C2 beige lyophilisate None 7.4-7.6*
Control wild-type blood donors, processed
* after reconstitution with deionized water
The controls consists of processed and lyophilized human plasma. None of the ingredients are
classified as dangerous acc. to the European Community Directive 93/112/EC amended 91/155/EC.
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MATERIAL SAFETY DATA SHEET
2.2. Hazardous ingredients CAS No Concentration EU Classification
Reagents 1,2:
Hexadimethrine Bromide 28728-55-4 < 0.1 % Xn
R 20/21/22
S 26
Reagent 1:
Human activated Protein C (APC) -- < 0.1 % --
Reagent 4:
Human Plasma (FNP) -- -- --
Controls 1,2:
Human Plasma (FNP) -- -- --
3. HAZARD IDENTIFICATION
Reagents 1,2:
Reagents containing hexadimethrine bromide in a lower concentration than 0.1 % are not classified as
dangerous acc. to the European Community Directive 93/112/EC amended 91/155/EC.
Reagents 1,4 and Controls 1,2:
Reagents and Control solutions containing human plasma* or human plasma derived material. They
should be handled with care, observing the precautions recommended for bio-hazardous material.
* The human plasma is tested on antibodies against HIV Typ 1 and 2, Hepatitis C-virus, Treponema pallidum and Hepatitis B surface antigen.
Hepatitis C was tested by PCR screen. The plasma was found to be negative. As complete absence of infectious agents can never be assured, all
materials derived from human or bovine tissue or body fluids should always be handled with care, observing the precautions recommended for
bio-hazardous material.
Emergency overview: general rules for handling biological material have to be followed
4. FIRST AID MEASURES
4.1. Skin Contact : Rinse with water, and wipe with skin disinfectant.
4.2. Eye Contact : Flush eyes immediately with water, if persistent
irritation occurs, seek medical advice.
4.3. Inhalation : Seek medical advice immediately.
4.4. Ingestion : Wash out mouth with water, seek medical advice
immediately.
4.5 Other first aid information : In case of injury and contamination with human
plasma material it is strongly recommended to consult
a physician.
5. FIRE FIGHTING MEASURES
5.1. Extinguishing media : Carbon dioxide, foam, dry powder, water
5.2. Unsuitable extinguishing media : None known
5.3. Unusual fire-fighting hazards : The products of combustion are toxic
5.4. Special fire-fighting procedure : None known
5.4. Other recommendations : No special precautions and measures necessary
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MATERIAL SAFETY DATA SHEET
6. ACCIDENTAL RELEASE MEASURES
6.1. Personal precautions : Avoid eye contact.
6.2. Precautions to protect : Keep away from drains and ground water.
environment
6.3. Cleanup procedures : Avoid dust formation. Sweep up and hold in suitable
containers for appropriate waste disposal.
7. HANDLING AND STORAGE
7.1. Handling precautions : In the case of accident avoid skin and eye contact
with the released material. Wear gloves and protect
yourself from injury by broken glass. No special
measures required.
7.2. Storage precautions : Refrigerator +2鈥?8掳C
7.3. Other information : Lyophilized reagents are hygroscopic. Keep vials
tightly closed.
8. EXPOSURE CONTROLS AND PERSONAL PROTECTION
8.1. Exposure controls : See 7.1.
8.2. Engineering control measures : No special control measures necessary.
8.3. Personal protective equipment
Respiratory protection : No respiratory protection is required when usual
industrial hygiene measures are observed.
Hand protection : Gloves
Eye protection : Safety glasses
Skin protection : Additional protective equipment is normally not
required
Other : --
9. PHYSICAL AND CHEMICAL PROPERTIES
9.1. Appearance /Colour : See 2.1.
Physical state : See 2.1.
Odor : See 2.1.
9.2. Safety related information
pH : See 2.1.
Other parameters : Not available or determined
10. STABILITY AND REACTIVITY
10.1. Conditions to avoid : Temperatures above 25掳C, freezing
10.2. Materials to avoid : None known
10.3. Hazardous decomposition : None known
products
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MATERIAL SAFETY DATA SHEET
11. TOXICOLOGICAL INFORMATION
11.1. Acute Toxicity
Hexadimethrine bromide : LDIo >1000 mg/kg (mouse/oral)
LD50 20 mg/kg (rat, i.v.)
LD50 30 mg/kg (rat, i.v.)
12. ECOLOGICAL INFORMATION
12.1. Ecotoxicity : No information available
13. DISPOSAL CONISDERATIONS
13.1. Product disposal : Incineration according to local and national legislation.
13.2. Packaging disposal : Dispose of in a manner in accordance with local and
national regulations.
14. TRANSPORT INFORMATION
14.1. UN. No. : Not applicable
14.2. Road and rail transport (ADR/RID) : Not applicable
14.3. Air transport (ICAO/IATA-DGR) : Not applicable
14.4. Sea transport (IMO/IMDG) : Not applicable
14.5. Inland navigation (AND(ADNR) : Not applicable
14.6. Other information : None
15. REGULATORY INFORMATION
15.1. Not classified as dangerous acc. to European Community Directive 93/21/EEC
15.2. National legislation:
For further product information, we recommend consideration of the corresponding
appropriate National Legislation.
16. OTHER INFORMATION
This Safety Data Sheet complies with the European Community Directive 93/112/EC amended
91/155/EC.
All information and instructions provided in this Safety Data Sheet are based on the current state of
scientific and technical knowledge a the date indicated on this Safety Data Sheet. Technoclone GmbH
shall not be held responsible for any defect in the product covered by this Safety Data Sheet, should
the existence of such a defect not be detectable considering the current state of scientific and
technical knowledge.
It characterizes the product with regard to the appropriate safety precautions. It does not represent a
guarantee of the properties of the product.
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