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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 pallidumtreponemal test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLIP
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 Not Third Party Eligible
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