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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
Submission Type PMA
Regulation Number 866.2420
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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