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U.S. Department of Health and Human Services

Product Classification

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Device antisera, fluorescent antibody for fta-abs test
Regulation Description Treponema pallidum treponemal test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGMX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3830
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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