OQO · Class II · 21 CFR 866.3305

FDA Product Code OQO: Herpes Simplex Virus Nucleic Acid Amplification Assay

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.

Leading manufacturers include Hologic, Inc. and Vela Diagnostics USA, Inc..

12
Total
12
Cleared
119d
Avg days
2010
Since

FDA 510(k) Cleared Herpes Simplex Virus Nucleic Acid Amplification Assay Devices (Product Code OQO)

12 devices
1–12 of 12
Cleared Feb 01, 2018
Sentosa SA201 HSV 1/2 Qualitative PCR Test
K172509
Vela Diagnostics USA, Inc.
Microbiology · 164d
Cleared Jun 15, 2017
Aptima Herpes Simplex Viruses 1 & 2 Assay
K162673
Hologic, Inc.
Microbiology · 262d

About Product Code OQO - Regulatory Context