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Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA product code OQO · 6 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3305
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2010-05-12 – 2018-02-01

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.

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