MATERIAL SAFETY DATA SHEET
1. IDENTIFICATION:
Name: Biophen Heparin 6
Product number: A221006
Kit composition: 4 vials of Chromogenic Factor Xa substrate, lyophilized (powder)
- 4 vials of Bovine Factor Xa, lyophilized (powder)
Manufacturer: HYPHEN BioMed
ZAC Neuville Universit茅 鈥? 155 rue d鈥橢ragny
95000 Neuville sur Oise (France)
Tel: 33.1.34.40.65.10
Fax: 33.1.34.48.72.36
2. APPLICATION/INTENDED USED:
This kit should be used only by suitable trained personnel, wearing the appropriate laboratory
protective clothing, particularly eye and skin protection. It must be used according strictly to the
instructions of package insert, and for the indicated purpose. The kit should be stored within the
manufacturer's box at the specified temperature (2-8掳C) and handled as per pack insert
instructions.
The information provided in this material safety data sheet is believed to be correct and does not
purport to be all inclusive and shall be used only as guide. HYPHEN BioMed and its appointed
agents/distributors or OEM contractors shall not be held liable for any damage resulting from or
from contact with the products included in the kit.
3. COMPOSITION/INFORMATION ON INGREDIENTS:
3.1 Chromogenic Factor Xa substrate, S Xa 11 :
Freeze dried powder contains Factor Xa chromogenic Substrate, SXa-11 (about 15 mg), Mannitol
(< 60 %), Tween 80 (< 12 %).
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3.2 Bovine Factor Xa :
Contains Bovine Factor Xa (< 0.1 %), Bovine Serum Albumin (< 5 %), sodium chloride (< 50 %),
Tris (Hydroxy-chloride) (< 50 %), Na2EDTA (<15 %), PEG6000 (<15 %), ciprofloxacin (< 0.001%).
4. TOXICITY HAZARDS:
Reagents Chemical CAS N掳 % or Classification LD50 (oral)
compounds weight
Factor Xa Substrate NA < 50 % NA NA
Substrate Mannitol 69-65-8 < 60 % NA NA
Tween 8O 9005-65-6 < 12 % R 40 ; S 36 7.5 ml/kg (rat)
Bovine Factor Xa NA < 0.001% NA NA
Factor Xa BSA NA <5% NA NA
Sodium Chloride 7647-14-5 < 50 % R36 526 LD50(rats) 3.75 g/kg
Tris 299-28-5 < 25 % S22-24/25 NA
Na2EDTA 6381-92-6 < 15 % R36/37/38 ; S 26-36 1.16 g/Kg (rats)
PEG6000 25322-68-3 < 15 % R36/38 S26-36 LD50 (rats) >50g/Kg
Ciprofloxacin NA < 0.001% NA NA
5. HEALTH HAZARDS DATA:
All the above listed chemicals or biologicals may be harmful by inhalation, ingestion, or skin
adsorption. Nasal irritation, eye reddening, and allergic reactions may result from overexposure.
First aid: - If swallowed, wash out mouth with water provided person is conscious. Medical advice
is necessary.
In case of contact with eyes, flush with copious amounts of water, for at least
-
15 minutes. Assure adequate flushing by separating the eyelids with fingers.
In case of inhalation, remove victim to fresh air, and seek medical advice.
-
In any case of overexposure, call a physician.
-
In case of contact, inhalation or ingestion of any of the components of the
-
Biophen Heparin 6 kit, seek immediately medical attention. If the victim is conscious, in case of
ingestion, drink several glasses of water (or milk), to dilute contents of stomach. Do not induce
vomiting.
Viral Safety: - Bovine Factor Xa is extracted from Bovine plasma, which has been tested
for bovine infectious diseases, and especially Bovine spongiform encephalitis (BSE), with
registered methods. However, all bovine material should be treated as potentially hazardous and
the appropriate handling and disposal procedures must be adhered to. No biological test may
totally exclude the presence of any infectious agent.
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6. FIRE AND EXPLOSION HARZAD DATA:
Flammability: Solutions are aqueous and non-flammable. Only carton boxes, dry chemical,
interiors inserts are flammable.
Extinguishing Media: Carbon dioxide, dry chemical powder or appropriate foam.
Special fire fighting procedures: Wear self-contained breathing apparatus and protective clothing
to prevent contact with skin.
7. REACTIVITY DATA:
Stability: Stable
Hazardous combustion or decomposition products: Carbon monoxide, carbon dioxide, nitrogen
oxide.
Hazardous polymerisation: Does not occur.
Chromogenic Substrate: When heated to dryness, the product may form hazardous
decomposition products.
8. SPILL, LEAK AND DISPOSAL PROCEDURES:
Steps to be taken if material is released or spilled:
- Sweep up, place in a bag and hold for waste material. Avoid raising dust. Ventilate area and
wash spill site after material pickup is complete.
- Waste disposal method:
Comply with all federal, state and local environmental regulations on waste handling and disposal.
- Chromogenic substrate:
Do not empty into drains or sinks. If a large amount of the product contaminates servages, Inform
appropriate authorities in accordance with local regulation. Comply to local rules for disposal of
wastes.
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9. ECOLOGY INFORMATION:
Do not empty chromogenic Factor Xa substrate or Bovine Factor Xa into waters or drains.
Comply with state and local environmental regulations. Usually wasted biological material is
stocked in hermetic specific containers for incineration by specialized companies.
Chromogenic Substrate is not readily biodegradable. This substrate is suspected to accumulate. It
is toxic to aqueous organisms, and may cause long term adverse effects in the aquatic
environment.
Use of the product can involve external environmental pollution. Do not empty into waters or
drains.
10. PRECAUTIONS TO BE TAKEN IN HANDLING AND STORAGE:
Must be only used by suitable trained and informed personnel.
Wear chemical resistant gloves, chemical safety goggles and protective laboratory clothing.
11. TOXICOLOGICAL INFORMATION:
All the components of the BIOPHEN Heparin kit are intended for in vitro use only, by experienced
and suitably trained personal. There is no special risk when used in these conditions. Products
may be toxic following skin or eye contact, inhalation or ingestion. For toxicity of components,
refer to chapters 4 and 5.
12. WASTE DISPOSAL CONSIDERATIONS:
Any waste product or reagent must be discarded according to local considerations.
Do not reuse vials or containers.
鈥淏iohazard鈥? risk is mentioned on the box
13. PHYSICAL AND CHEMICAL PROPERTIES:
Both reagents R1 and R2 of the BIOPHEN Heparin kit are lyophilized powder.
They do not present any specific physical or chemical reactivity, and are stable compounds.
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14. TRANSPORT AND STORAGE INFORMATION:
The BIOPHEN Heparin kit must be shipped adequately packaged and protected from any break
during transportation.
It can be shipped at ambient temperature for a short period, not exceeding 7 days. It must be
stored in a cold room at 2-8掳C upon receipt.
No special regulation for transporting this product.
General rules for in vitro diagnostic should apply.
Local, State and Federal regulations for this kind of product must be respected.
The kit must be stored in an appropriate refrigerated area, specifically dedicated for in vitro
diagnostic kits.
All the storage constraints are indicated on the package labels and on the kit insert.
15. REGULATORY INFORMATION:
This assay is designed, manufactured, controlled and followed according to the directive
98/79/CE from European parliament and council, (October 27th, 1998) related to the in vitro
diagnostic medical device.
It is labelled with the CE mark.
Risk analysis has been performed and reduced to the lowest level available from the present
knowledge.
16. OTHER INFORMATION:
For in vitro diagnostic use only.
Disclaimer: The information reported on this MSDS is believed to be accurate and represents
the best information available to us. However, we make no warranty of merchantability or any
other warranty, expressed or implied, with respect to such information, and we assure no liability
resulting from its use. Users should make their own investigations to determine the suitability of
the information for their particular purposes.
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