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MSDS Material Safety Data Sheet
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File Name: innotrac_fi---troponin.msds.en.asp
MATERIAL SAFETY DATA SHEET                                                                      Date: 26.01.2005
For 2nd generation Innotrac Aio! Troponin I kit

1. IDENTIFICATION OF THE CHEMICAL AND OF THE MANUFACTURER, IMPORTER OR OTHER
UNDERTAKING
1.1 Identification of the substance or preparation:
nd
Trade Name: 2 generation Innotrac Aio! Troponin I kit
Code of the product: 115-0010
1.2 Identification of the manufacturer, importer or other undertaking:
Manufacturer: Innotrac Diagnostics Oy
Street address: Kalevantie 25
Postcode and post office: FI-20520 Turku, Finland
Telephone number: + 358-2-2784000
Telefax: + 358-2-2784001
LY code: FI 1032053-4
1.3 Name and address of the informant in emergency cases:
Myrkytystietokeskus, PL 340, Haartmaninkatu 4, FI-00029 HUS
Emergency telephone number: +358-9-471977
1.4 Information on the foreign manufacturer: None

2. COMPOSITION AND INFORMATION ON INGREDIENTS
2.1 Description: Kit contains 10 analyte and 1 calibrator pens packed in an aluminium foil which contains
silica gel as an adsorbent. Analyte pen contains 12 analyte specific cups and calibrator pen 3 analyte
specific and 9 calibrator cups with dry chemical reagents.
2.2 Hazardous ingredients:
2.2.1 CAS 2.2.2 Name of the 2.2.3 2.2.4 Warning symbol, R phases and other
number or other ingredient Concentration data on the ingredient
code


2.2.5 Full chemical name of the ingredient (CAS number: name) Confidential
2.2.6 Other information:
Human source material. Treat as potentially infectious.
Each serum/plasma donor unit used in the manufacture of this product has been tested by FDA accepted
methods and found non-reactive for the presence of HBsAg and antibodies to HIV-1/2, HCV and HIV-1
Ag. While these methods are highly accurate, they do not guarantee that all infected units will be
detected. Because no known test method can offer complete assurance the hepatitis B virus, hepatitis C
virus, human immunodeficiency virus (HIV) or other infectious agents are absent, all products containing
human source material should be considered potentially infectious and handled with the same
precautions used with patient specimens. Please refer to the U.S. Department of Health and Human
Services publication "Biosafety in Microbiological and Biomedical Laboratories" or any other local or
national regulation.
nd
2 generation Innotrac Aio! troponin I kit (115-0010) contains:
- 10 analyte pens for performing 120 assays
- 1 calibrator pen for performing a calibration adjustment

The kit reagents do not contain hazardous chemicals in reportable quantity (sodium azide < 0.1%).

3. HAZARDS IDENTIFICATION

4. FIRST AID MEASURES
4.1 Special instructions: All recommended precautions for the handling of blood derivates should be
observed.
4.2 Inhalation: -
4.3 Skin: -
4.4 Splashes in eyes: -
4.5 Ingestion: -
4.6 Information to doctor or other trained persons giving first aid: -


Page 1/4
MATERIAL SAFETY DATA SHEET Date: 26.01.2005
For 2nd generation Innotrac Aio! Troponin I kit

5. FIRE-FIGHTING MEASURE
5.1 Suitable extinguishing media: water, foam, carbon dioxide
5.2 Extinguishing media which must not be used for safety reasons: -
5.3 Special exposure hazards in a fire: -
5.4 Special protective equipment for a fire: -
5.5 Other instructions: -

6. ACCIDENTAL RELEASE MEASURES
6.1 Personal precautions: -
6.2 Environmental precaution: -
6.3 Methods for cleaning up: -
6.4 Other instructions: -

7. HANDLING AND STORAGE
7.1 Handling:
This kit contains reagents manufactured from human tissue components. Treat them as potentially
infectious.Handle all patient specimens as potentially infectious. All recommended precautions for the
handling of tissue and blood derivatives should be observed. Please refer to the U.S. Department of
Health and Human Services publication "Biosafety in Microbiological and Biomedical Laboratories" or any
other local or national regulation.
7.2 Storage: Store at +2 鈥? +8潞C. The expiry date of the kit is stated on the outer label. Make sure that the
plastic bag remains sealed.

8. EXPOSURE CONTROL/PERSONAL PROTECTION
8.1 Technical measures for exposure controls: -
8.2 Limit values for workplace air: -
8.3 Personal protective equipment:
8.3.1 Special instruction for protection and hygiene: -
8.3.2 Respiratory protection: -
8.3.3 Hand protection: -
8.3.4 Eye protection: -
8.3.5 Skin protection: -

9. PHYSICAL AND CHEMICAL PROPERTIES
9.1 Physical state, color and odor: colorless and odorless solid reagents in a cup
9.2 pH: -
9.3 Information on changes in the physical state:
9.3.1 Boiling point/boiling range: -
9.3.2 Melting point/melting range: -
9.3.3 Decomposition temperature: -
9.4 Flash point: -
9.5 Flammability (solid/gas): -
9.6 Autoflammability: -
9.7 Explosion hazard: -
9.8 Explosive limits:
a) lower -
b) upper -
9.9 Oxidizing properties: -
9.10 Vapour pressure: -
9.11 Relative density: -
9.12 Solubility:
a) water solubility: cup reagents are soluble
b) fat solubility: -
9.13 Partition coefficient (for ingredients): -
9.14 Viscosity: -
9.15 Other information: -

Page 2/4
MATERIAL SAFETY DATA SHEET Date: 26.01.2005
For 2nd generation Innotrac Aio! Troponin I kit

10. STABILITY AND REACTIVITY
10.1 Conditions to avoid: -
10.2 Materials to avoid: -
10.3 Hazardous decomposition products: -

11. TOXICOLOGICAL INFORMATION
11.1 Acute toxicity: The cup contains sodium azide < 0.1%when buffer is added.
11.2 Irritation and corrosiveness: -
11.3 Sensitization: -
11.4 Subacute, subchronic and prolonged toxicity: -
11.5 Empirical data on effects on humans: -
11.6 Other information on health effects: -

12. ECOLOGICAL INFORMATION
12.1 Persistence in the environment:
12.1.1 Biodegradation: -
12.1.2 Chemical degradation: -
12.2 Bioaccumulation: -
12.3 Mobility: -
12.4 Toxic effects on organisms:
12.4.1 Aquatic toxicity: -
12.4.2 Other toxicity: -
12.5 Other information: -

13. DISPOSAL CONSIDERATIONS
Disposal of all waste should be in accordance with local regulations.

14. TRANSPORT INFORMATION
14.1 UN number: -
14.2 Packaging category: -
14.3 Land transport:
14.3.1 Transport class: -
14.3.2 Risk code: -
14.3.3 Name according to bill of freight: -
14.3.4 Other information: -
14.4 Sea transport:
14.4.1 IMDG class: -
14.4.2 Correct technical name: -
14.4.3 Other information: -
14.5 Air transport:
14.5.1 IDAO/IATA class: -
14.5.2 Corrective technical name: -
14.5.3 Other information: This product is not a subject to transport regulations.

15. REGULATORY INFORMATION
15.1 Information on the warning label:
15.1.1 Letter code of the warning symbol and indications of danger for the preparation: -
15.1.2 Names of the ingredients given on the warning label: -
15.1.3 R phrases: -
15.1.4 S phrases: -
15.1.5 Special regulations on certain preparations: -
15.2 National regulations: -




Page 3/4
MATERIAL SAFETY DATA SHEET Date: 26.01.2005
For 2nd generation Innotrac Aio! Troponin I kit

16. OTHER INFORMATION
16.1 Purpose of use:
16.1.1 Expressed in writing:
Kit is manufactured for in vitro diagnostic use for quantitative determination of troponin I in human EDTA
whole blood, EDTA plasma, lithium heparin whole blood, lithium heparin plasma and serum samples as
for the early detection of acute myocardial infarction using the fully automated Innotrac Aio!
Immunoanalyzer.
16.1.2 Code for the purpose of use: -
SIC1: KT1:
SIC2: KT2:
SIC3: KT3:
SIC4: KT4:
SIC (TOL) 鈥? Standard industrial classification
KT 鈥? Desired effect of the chemical
16.2 Directions for use: See manufacturer鈥檚 instruction for use
16.3 Other information:
The above information is believed to be correct, but does not purport to be all inclusive and shall be used
only as a guide. Innotrac Diagnostics Oy shall not be held liable for any damage resulting from handling
or form contact with the above product.
16.4 Additional information available from: manufacturer
16.5 Sources of information used in the compilation of the safety data sheet:
Information given by manufacturer.

Reasons for the confidentiality of the information




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