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U.S. Department of Health and Human Services

Product Classification

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Device test, hepatitis b (b core, be antigen, be antibody, b core igm)
Review Panel Microbiology
Product CodeLOM
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Review Criteria for Devices Intended for the Detection of Hepatitis B 'e' Antigen and Antibody to HBe [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094265.pdf] 
Third Party Review Not Third Party Eligible
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