MATERIAL SAFETY DATA SHEET
1. PRODUCT IDENTIFICATION
Product Name: ACTICHROME?MP Activity
Product No.: 817
Configuration: 96 well ELISA, 12 strips each of 8 wells
Use of Product: Measurement of Microparticle Activity
Manufacturer: American Diagnostica Inc.
500 West Avenue
Stamford, CT 06902 USA
Tel: (203) 602 7777
Fax: (203) 602 2221
2. COMPOSITION/INFORMATION ON INGREDIENTS
Percent/
Reagent/Component Chemical Name CAS Number LD50
Weight
Human Annexin V N/A N/A N/A
Annexin V Coated Microwells
Biotin 58-85-5 N/A N/A
SiO2 (silica gel desiccant packet) 7631-86-9 3g Do Not Ingest
Tris 126-11-4 < 2.0% rat, oral - 1900 mg/kg
Sample Diluent-MP
Sodium Chloride 7647-14-5 < 2.0% rat, oral - 3000 mg/kg
Bovine Serum Albumin 9048-46-8 < 2.0% N/A
Kathon CG 26530-20-1 < 0.1% N/A
Calcium Chloride 10043-52-4 < 2.0% mouse, i.v. ?42.2 mg/kg
PAB 532-32-1 < 0.2% N/A
Ciprofloxacine 85721-33-1 < 0.01% N/A
Sodium Azide 26628-22-8 < 0.1% rat, oral ?45 mg/kg
Bovine FVa-FXa N/A < 1.0% N/A
R1 ?Bovine FVa-FXa Mixture
Tris 126-11-4 < 0.83% rat, oral - 1900 mg/kg
Sodium Chloride 7647-14-56 < 0.83% rat, oral - 3000 mg/kg
Bovine Serum Albumin 9048-46-8 < 0.33% N/A
Ciprofloxacine 85721-33-1 < 0.001% N/A
Human Prothrombin 9001-26-7 < 1.0% N/A
R2 ?Human Prothrombin
Tris 126-11-4 < 0.83% rat, oral - 1900 mg/kg
Sodium Chloride 7647-14-56 < 0.83% rat, oral - 3000 mg/kg
Bovine Serum Albumin 9048-46-8 < 0.33% N/A
Ciprofloxacine 85721-33-1 < 0.001% N/A
R3 ?Thrombin Specific Substrate N/A < 30% N/A
Chromogenic Substrate Mannitol 69-65-8 > 70% N/A
Human Platelet lysate N/A < 1.0% N/A
Calibrator
Tris 126-11-4 < 0.5% rat, oral ?1900 mg/kg
Calcium Chloride 10043-52-4 < 0.1% mouse, i.v. ?42.2 mg/kg
Bovine Serum Albumin 9048-46-8 < 0.5% N/A
Ciprofloxacine 85721-33-1 < 0.001% N/A
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500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 Tel. (203) 602-7777 Fax. (203) 602-2221
Human Plasma 9001-26-7 < 4.0% N/A
Control I
Glycine 50-46-6 < 50% N/A
Bovine Serum Albumin 9048-46-8 < 60% N/A
Ciprofloxacine 85721-33-1 < 0.002% N/A
Human Plasma 9001-26-7 < 4.0% N/A
Control II
Glycine 50-46-6 < 50% N/A
Bovine Serum Albumin 9048-46-8 < 60% N/A
Ciprofloxacine 85721-33-1 < 0.002% N/A
Tris 126-11-4 < 10.0% rat, oral - 1900 mg/kg
Wash Solution
Sodium Chloride 7647-14-5 < 10.0% rat, oral - 3000 mg/kg
Tween 20 9005-64-5 < 2.0% rat, oral ?36700 礸/kg
Kathon CG 26530-20-1 < 0.1% N/A
Sodium Azide 266-22-8 < < 0.1% rat, oral ?45 mg/kg
Citric Acid C6H8O7稨2O 5949-29-1 2.0% rat, oral ?6.73 g/kg
3. HAZARDS IDENTIFICATION
Potential Health Hazards
Eye Exposure: May be harmful by eye exposure.
Dermal Exposure: May be harmful if absorbed through the skin.
Oral Exposure: May be harmful if swallowed.
Inhalation Exposure: May be harmful if inhaled. Irritating to mucous membranes and the upper respiratory tract.
4. FIRST AID MEASURES
Eye Exposure: 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. Seek medical attention.
Dermal Exposure: In case of skin contact, flush with copious amounts of water for at least 15 minutes. Remove
contaminated clothing.
Oral Exposure: If swallowed, wash out mouth with water provided person is conscious. Seek medical attention.
Inhalation Exposure: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult,
administer oxygen.
5. FIRE FIGHTING MEASURES
Flammability: Solutions are non-flammable. Boxing, instruction papers and powdered reagents are flammable.
Extinguishing Media: Use extinguishing media appropriate to the surrounding fire conditions, such as carbon dioxide, dry
chemical powder or foam.
Fire Fighting Instructions: Wear self-contained breathing apparatus and protective clothing appropriate for fighting a fire
involving chemical materials to prevent contact with skin and eyes.
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500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 Tel. (203) 602-7777 Fax. (203) 602-2221
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions: Wear respirator, chemical safety goggles, rubber boots and heavy rubber gloves. In case of skin
contact, flush with copious amounts of water and remove contaminated clothing.
Methods For Cleaning Up: Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and
wash spill site after material pickup is complete. Do not empty into drains.
7. HANDLING AND STORAGE
Handling: Avoid inhalation. Avoid contact with eyes, skin and clothing.
Storage: The product is stable until the expiration date stated on its labeling when stored at 2?8癈.
Safety: The source material for the plasma/serum-based reagent(s) has been found to be non-reactive for
Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus
Type 1 and Type 2 (HIV-1, HIV-2) using registered methods. As no known test method can
provide complete assurance that products derived from human blood will not transmit HBsAg,
HCV, HIV-1, HIV-2 or other blood-borne pathogens, this reagent should be handled as
recommended for any potentially infectious human specimen.
The source material for reagents prepared from bovine plasma was collected from animals free
from BSE and tested for the absence of infectious agents. As no known test method can provide
complete assurance that products derived from animal blood will not transmit blood-borne
pathogens, these reagents should be handled as recommended for any potentially infectious
specimen.
Warning: Several reagents contain sodium azide, which may react with lead and copper plumbing to form
highly explosive metal azides. Upon disposal, flush sinks and drains with large volumes of water.
Hygienic Practice: Wash hands with soap and water following use.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Eye/Face Protection: Chemical safety goggles.
Hand Protection: Compatible chemical resistant gloves.
Respiratory Protection: NIOSH (USA) or CEN (EU) approved respirator. Mechanical exhaust required.
Skin Protection: Compatible chemical resistant gloves and other protective clothing as required preventing skin
contact.
General Hygiene Practices: Wash promptly if skin comes into contact with product. Wash thoroughly after handling. Remove
any clothing that comes into contact with the product. Do not smoke or eat in the work
environment.
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500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 Tel. (203) 602-7777 Fax. (203) 602-2221
9. PHYSICAL AND CHEMICAL PROPERTIES
Annexin V R1 ?Bovine FXa- R2 ?Human R3 ?Thrombin
Property Sample Diluent
Microwells FVa Prothrombin Substrate
white, lyophilized white, lyophilized white, lyophilized
Appearance N/A clear liquid
powder powder powder
Odor N/A N/A N/A N/A N/A
pH N/A N/A N/A N/A N/A
Freezing Point N/A N/A N/A N/A N/A
Vapor Pressure N/A N/A N/A N/A N/A
Specific Gravity N/A N/A N/A N/A N/A
Solubility N/A N/A water soluble water soluble water soluble
Evaporation Rate N/A N/A N/A N/A N/A
Viscosity N/A N/A N/A N/A N/A
Surface Tension N/A N/A N/A N/A N/A
Boiling Point N/A N/A N/A N/A N/A
Melting Point N/A N/A N/A N/A N/A
Flash Point N/A N/A N/A N/A N/A
Lower Explosive Limit N/A N/A N/A N/A N/A
Upper Explosive Limit N/A N/A N/A N/A N/A
Flammability N/A N/A N/A N/A N/A
Autoignition Temp. N/A N/A N/A N/A N/A
Property Calibrator Control I Control II Wash Solution Citric Acid
white, lyophilized straw-colored, straw-colored,
Appearance clear liquid clear liquid
powder lyophilized powder lyophilized powder
Odor N/A N/A N/A N/A N/A
pH N/A N/A N/A N/A 4-5
Freezing Point N/A N/A N/A N/A N/A
Vapor Pressure N/A N/A N/A N/A N/A
Specific Gravity N/A N/A N/A N/A N/A
Solubility water soluble water soluble water soluble N/A NA
Evaporation Rate N/A N/A N/A N/A N/A
Viscosity N/A N/A N/A N/A N/A
Surface Tension N/A N/A N/A N/A N/A
Boiling Point N/A N/A N/A N/A N/A
Melting Point N/A N/A N/A N/A N/A
Flash Point N/A N/A N/A N/A N/A
Lower Explosive Limit N/A N/A N/A N/A N/A
Upper Explosive Limit N/A N/A N/A N/A N/A
Flammability N/A N/A N/A N/A N/A
Autoignition Temp. N/A N/A N/A N/A N/A
N/A = not available
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500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 Tel. (203) 602-7777 Fax. (203) 602-2221
10. STABILITY AND REACTIVITY
Stability: Stable.
Incompatible Materials: Strong oxidizing reagents. Reducing agents (Citric Acid).
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides.
Hazardous Polymerization: Does not occur.
11. TOXICOLOGICAL INFORMATION
Toxicity Data : See Section 2
The health effects noted above are based on the extrapolation of data on the pure product ingredients. To the best of our knowledge,
no health effects have been identified for the product mixture under normal conditions of use, although the health effects of the
product have not been thoroughly investigated.
12. ECOLOGICAL INFORMATION
Use in accordance with good laboratory practices. Do not waste into the environment. An environmental hazard cannot be excluded
in the event of unprofessional handling or disposal.
13. DISPOSAL CONSIDERATIONS
Contact a licensed professional waste disposal service to dispose of this material. Disposal should be made in accordance with
existing disposal practices employed for infectious waste at your institution. Observe all federal, state and local environmental
regulations and laws.
This product is classified as harmful.
Reference: Italian Legislative Decree 152/2006 and the following modifications.
Decision 2000/532/EC of May 3, 2000 and modifications.
14. TRANSPORT INFORMATION
DOT: Proper Name For Shipping: Non-hazardous for air transport
IATA:/ICAO Proper Name For Shipping: Non-hazardous for air transport
ADR (road): Proper Name For Shipping: Non-hazardous for air transport
RID (rail): Proper Name For Shipping: Non-hazardous for air transport
15. REGULATORY INFORMATION
This product is classified and labeled in accordance with Directive 1999/45/EC and the following modifications. The health hazard
classification has been determined based upon the composition and hazard data of each ingredient. Physical and health hazard
information on the reagent mixture has not been determined. Any physical and health hazard information noted is based on a)
evaluation of data of the pure ingredient and b) the concentration of each ingredient.
OSHA Hazard: Mild skin irritant, Mild eye irritant
Hazard Classification
EC Symbol: Xi
Indication of Danger: Irritant.
Risk Code: 28-32/36/37/38-50
Safety Code: 22-24/25-26-28-36-45-53-60/61
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500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 Tel. (203) 602-7777 Fax. (203) 602-2221
US Classification
Indication of Danger: Irritant.
Risk Statement: Irritating to eyes, respiratory system and skin.
Safety Statements: In case of contact with eyes, rinse immediately with plenty of water and seek medical attention.
Wear suitable protective clothing.
United States Regulatory Information
SARA Listed: No
Canada Regulatory Information
DSL: No
NDSL: No
16. OTHER INFORMATION
This Material Safety Data Sheet has been drawn in accordance with Directive 2001/58/EC.
The information supplied in this Material Safety Data Sheet represents the data and best information available on the date of
preparation. It is provided to allow for the proper and safe use, storage, transport and disposal of the product. It is not to be
considered as a warranty, guarantee or specification of the product quality. It is related to the materials specifically indicated and
does not apply if these are used in combination with other materials or during processes not indicated in the text of this safety data
sheet.
American Diagnostica Inc. shall not be held liable for any damage resulting from handling or from contact with the above product.
817MSDS〢DI20071002
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500 West Avenue, P.O. Box 110215, Stamford, CT 06911-0215 Tel. (203) 602-7777 Fax. (203) 602-2221
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