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 Vela Diagnostics USA, Inc., Becton, Dickinson & CO and Quidel Corporation.

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
Cleared Jun 01, 2015
cobas HSV 1 and 2 Test
K150617
Roche Molecular Systems, Inc.
Microbiology · 83d
Cleared Mar 26, 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029
Quidel Corporation
Microbiology · 79d
Cleared Mar 18, 2011
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
K103798
Becton, Dickinson & CO
Microbiology · 81d

About Product Code OQO - Regulatory Context