OQO

Herpes Simplex Virus Nucleic Acid Amplification Assay

Product code: OQO
Device name: Herpes Simplex Virus Nucleic Acid Amplification Assay
Device class: Class 2
21 CFR: 21 CFR 866.3305
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 12 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OQO

Classification and pathway per current FDA publications. Data from openFDA (CC0).