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U.S. Department of Health and Human Services

Product Classification

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Device hepatitis a test (antibody and igm antibody)
Regulation Description Hepatitis A virus (HAV) serological assays.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLOL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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