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U.S. Department of Health and Human Services

Product Classification

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Device antiserum, fluorescent (direct test), all groups, n. gonorrhoeae
Regulation Description Neisseria spp. direct serological test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGTH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3390
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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