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U.S. Department of Health and Human Services

Product Classification

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Device assay, genotype, hiv drug resistance, in vitro
Regulation Description In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
Definition Hiv-1 drug resistance genotyping
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNHS
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 866.3950
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible