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U.S. Department of Health and Human Services

Product Classification

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Device antigens, nontreponemal, all
Regulation Description Treponema pallidum nontreponemal test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGMQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3820
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons