Herpes Simplex Virus Nucleic Acid Amplification Assay

OQO · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3305

Classification

FDA Product Code: OQO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3305
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 12
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown