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