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U.S. Department of Health and Human Services

Product Classification

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Device herpes simplex virus nucleic acid amplification assay
Regulation Description Herpes simplex virus serological assays.
Definition A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.
Physical State Plasma, serum, swab, culture isolates
Technical Method Polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV) DNA
Target Area Systemic
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOQO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3305
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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