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SAFETY DATA SHEET

Premier Resolution FASC Position Marker Kit
EC 1272/2008 (CLP/GHS)

Section 1: Identification of the Substance/Mixture and of the Company/Undertaking

1.1 Product Identifiers Product Name: Premier Resolution FASC Position Marker Kit
Product Code: 01-04-0046
Product Description: Kit consisting of two vials of lyophilized hemoglobin F,
A, S and C position markers for use with the Trinity
Biotech Premier Hb9210 Resolution HPLC Analyzer.
For in vitro diagnostic use only.

1.2 Relevant Uses Identified Uses: Position marker material for HPLC laboratory instrument
use. For use with the Premier Hb9210 Resolution Analyzer
only. No other uses intended. No substitutions are
permitted, registered or authorized.
Uses Advised Against: The material has no uses separate from the analyzer.
No other uses are permitted, registered or
authorized.

1.3 Supplier Details Manufacturer: Trinity Biotech

th
4231 E. 75 Terrace
Kansas City, MO 64132

EC REP and International Contact:

Trinity Biotech plc
IDA Business Park
Bray Co. Wicklow
Bray, Ireland
Telephone: 353 1 276 9800
353 1 276 9888

1.4 Emergency Telephone Contact the local emergency telephone number / poison center
Number
Or + 353 1 276 9800 Trinity Biotech Technical Support Group

Trinity Biotech  4231 E. 75th Terrace  Kansas City, MO 64132 USA

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Section 2: Hazards Identification

2.1 Classification Not a hazardous substance or mixture. This product is not classified as
hazardous per EC 1272/2008 (CLP/GHS).

2.2 Label Elements Not a hazardous substance or mixture. This product does not have to be
labeled under the calculation procedure and concentration thresholds of the
CLP classification guideline.

2.3 Other Hazards None. Not otherwise classified (HNOC) or covered by GHS.
Contains human blood source material. Donor units are tested to verify non-
reactive for Hepatitis B surface antigen, HIV 1 and 2 and HCV antibodies.
However, no known test method can assure product derived from human
blood does not contain any biological hazard. For added precaution use
universal precautions and handle as if potentially infectious.

Section 3: Composition on Ingredients

3.1 Substance Not a pure substance. See mixture information below.

3.2 Mixture Mixture of non hazardous substances with preservative addition:

Contains CAS No. EC No. Index No. Percentage Classification

Hemolysate prepared from
packed red blood cells 62572-11-6 None 90-100% Not classified
(human erythrocytes)

Section 4: First Aid Measures

4.1 First Aid Measures General: Remove source of contact, thoroughly wash and rinse affected area.
Inhalation: Not volatile.
Skin Contact: Rinse area with water, wash with soap and rinse thoroughly.
Eye Contact: Rinse opened eye for several minutes under running water or
eye rinse solution.
Swallowing: Rinse mouth thoroughly.

4.2 Symptoms and Effects Acute: May be irritating to eyes if not rinsed.
Delayed: May be irritating to skin if not rinsed and washed.

4.3 Immediate Medical See Section 4.1. No other information available.

Attention and Special
Treatment Needed

Trinity Biotech  4231 E. 75th Terrace  Kansas City, MO 64132 USA

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Section 5: Firefighting Measures

5.1 Extinguishing Media Not flammable or combustible. Use CO2, powder or water spray.

5.2 Special Hazards No special hazards known.

5.3 Advice for Firefighters No special measures required.

Section 6: Accidental Release Measures

6.1 Personal Precautions, Use gloves to avoid contact. Handle as potential biohazard or biological
Protective Equipment waste using universal precautions.
and Emergency
Procedures

6.2 Environmental No significant environmental hazards.

Precautions
Containment and
6.3 Clean Up Use liquid absorbing materials for clean up.

6.4 Reference to See Section 7 for Handling and Storage.

Other Sections See Section 8 for Personal Protection.

Section 7: Handling and Storage

7.1 Safe Handling No special measures for handling.

7.2 Safe Storage and No special safety requirements for storage.

Incompatibilities

7.3 Specific Uses For use with the Premier Resolution Analyzer only. No other uses intended.

Section 8: Exposure Controls / Personal Protection

8.1 Control Parameters No special hazards, controls or monitoring required.

8.2 Exposure Controls Use nitrile, latex or similar liquid proof gloves to avoid contact. Handle as
biological waste using universal precautions.

Trinity Biotech  4231 E. 75th Terrace  Kansas City, MO 64132 USA

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Section 9: Physical and Chemical Properties

9.1 Physical and Physical Properties

Chemical Properties
Form Dried powder in glass vial.

Color Red to pink in color.

Chemical Properties

pH at 20 °C 7-8

Boiling Point N/A

Flash Point None

Flammability Not flammable

Density 1.0 g/ml (hydrated)

Solubility Not soluble.

Solvent Content Water 90-100%, Organic Solvent: 0 %

9.2 Other Information None

Section 10: Stability and Reactivity

10.1 Reactivity Not reactive

10.2 Chemical Stability Stable

10.3 Hazardous Reactions No known hazardous reactions

10.4 Conditions to Avoid No known conditions to avoid

10.5 Incompatible Materials No known incompatible materials

10.6 Hazardous No known hazardous decomposition products

Decomposition
Products

Trinity Biotech  4231 E. 75th Terrace  Kansas City, MO 64132 USA

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Section 11: Toxicological Information

11.1 Information on
Toxicological Effects Acute Toxicity None. No acute hazards. No data available.

Inhalation None. Not volatile. No data available

Dermal Prolonged contact on skin could cause skin irritation.

Eye Prolonged contact with eye could cause eye irritation.

Sensitization No sensitization effects. No data available.

Germ Cell Based on available data, no germ cell mutagenicity

Mutagenicity classification criteria are met.

Carcinogenicity Based on available data, no carcinogenicity classification

criteria are met.

Reproductive Based on available data, no reproductive toxicity classification

Toxicity criteria are met.

STOT-Single Based on available data, no classification criteria are met.

Exposure

STOT-Repeated Based on available data, no classification criteria are met.

Exposure

Aspiration Hazard Based on available data, no classification criteria are met.

Section 12: Ecological Information

12.1 Toxicity No ecological toxicity hazard.

12.2 Persistence and No persistence in the environment. Readily biodegrades.

Degradability

12.3 Bioaccumulative No bioaccumulation.

Potential

12.4 Mobility in Soil No mobility in soil.

12.5 Results of PBT and Not applicable.

vPvB Assessment

12.6 Other Adverse Effects None.

Trinity Biotech  4231 E. 75th Terrace  Kansas City, MO 64132 USA

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Section 13: Disposal Considerations

13.1 Waste Treatment Handle as biological waste. Disposal must be made according to local
Methods regulations.

Section 14: Transport Information

14.1 UN Number Not a dangerous goods for transport.

14.2 UN Proper Shipping Not a dangerous goods for transport.

Name

14.3 Transport Hazard Not a dangerous goods for transport.

Classes

14.4 Packing Group Not a dangerous goods for transport.

14.5 Environmental Hazards Not a dangerous goods for transport.

14.6 Special Precautions Not a dangerous goods for transport.

for User

14.7 Bulk Transport Not packaged or transported in bulk. Not a dangerous goods for transport.

Section 15: Regulatory Information

15.1 Safety, Health and No components exceed de minimis thresholds for special handling under
Environmental safety, health and environmental regulations.
Regulations

15.2 Chemical Safety A separate chemical safety assessment has not been carried out.
Assessment

Section 16: Other Information

16.1 Other Information The information contained in this SDS has been prepared based on present
knowledge, but shall not constitute a guarantee for any specific product
feature and shall not establish a legally valid or contractual relationship.

Trinity Biotech  4231 E. 75th Terrace  Kansas City, MO 64132 USA