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U.S. Department of Health and Human Services

Product Classification
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Device device, oxidase test for gonorrhea
Regulation Description Oxidase screening test for gonorrhea.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLGA
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type PMA
Regulation Number 866.2420
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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