A1cNow

Metrika, Inc

Revision date : 2002-04-02

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

General Information

Revision date

2002-04-02

Product name

A1cNow

1.2.1 Relevant identified uses

in vitro diagnostic test for HbA1c in fingerstick or venous whole blood

Manufacturer Name

Metrika, Inc

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Company Information

company name

Metrika, Inc

Section 2

Product definition

A1cNow consists of a disposable plastic-encased device (the monitor) and ancillary disposable components for: collecting the blood sample (small capillary pipet), preparing the diluted sample (vial of buffered detergent solution), and delivering the diluted sample to the monitor (transfer pipet). The primary active ingredient of the buffered detergent solution (approximately 2% of the solution) is trade secret. The monitor is fully-contained with no exposed reagents or electronics. The monitor contains two alkaline miniature batteries (total 3 volts), but these batteries are not exposed to the user under normal conditions of use. SECTION 3 HEALTH HAZARDS Potential Routes of Exposure: eye contact, skin contact, inhalation, accidental ingestion Eye: contact may cause eye irritation Skin: contact may cause skin irritation Inhalation: none known Accidental ingestion: none known Chronic Toxicity: none known Reproductive and Developmental Toxicity: The chemicals in the buffered detergent solution are not considered reproductive or developmental toxins at exposure less than or equal to established occupational limits. Carcinogenicity: None of the chemicals in the buffered detergent solution are listed as carcinogens or potential carcinogens. Medical Conditions Aggravated by Exposure: unknown

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