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U.S. Department of Health and Human Services

Product Classification

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Device gonococcal antibody tests
Regulation Description Gonococcal antibody test (GAT).
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLGB
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type PMA
Regulation Number 866.3290
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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