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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 Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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