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U.S. Department of Health and Human Services

Product Classification

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Device test,donor,syphilis,antigens,treponemal
Regulation Description Treponema pallidum treponemal test reagents.
Regulation Medical Specialty Microbiology
Review Panel Immunology
Product CodeMYR
Premarket Review Center for Biologics Evaluation & Research (CBER)
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
Accredited Persons