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U.S. Department of Health and Human Services

Product Classification

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Device antisera, control for nontreponemal tests
Regulation Description Treponema pallidumnontreponemal test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGMP
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
Third Party Review
Accredited Persons

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