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U.S. Department of Health and Human Services

Product Classification

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Device enzyme linked immunoabsorption assay, treponema pallidum
Regulation Description Treponema pallidum treponemal test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLIP
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible