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U.S. Department of Health and Human Services

Product Classification

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Device hemoglobin a1c test system
Regulation Description Hemoglobin A1c test system.
Definition Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Physical State In-Vitro Diagnostic Reagent Kit
Technical Method Turbidimetric inhibition immunoassay
Target Area In-Vitro Diagnostic for use with Whole blood
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePDJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1373
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible