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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
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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