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 Qiagen, Roche Molecular Systems, Inc. and Focus Diagnostics.
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
Cleared
Feb 01, 2018
Sentosa SA201 HSV 1/2 Qualitative PCR Test
Vela Diagnostics USA, Inc.
Microbiology
164d
Cleared
Jun 15, 2017
Aptima Herpes Simplex Viruses 1 & 2 Assay
Hologic, Inc.
Microbiology
262d
Cleared
Aug 28, 2015
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Focus Diagnostics
Microbiology
140d
Cleared
Jun 01, 2015
cobas HSV 1 and 2 Test
Roche Molecular Systems, Inc.
Microbiology
83d
Cleared
Feb 13, 2015
SEEGENE ANYPLEX II HSV-1/2 ASSAY
Seegene
Microbiology
191d
Cleared
Dec 19, 2014
artus HSV-1/2 QS-RGQ MDx Kit
Qiagen
Microbiology
87d
Cleared
May 13, 2014
IMDX HSV-1/2 FOR ABBOTT M2000
Intelligent Medical Devices, Inc.
Microbiology
106d
Cleared
Mar 26, 2014
AMIPLIVUE HSV 1&2 ASSAY
Quidel Corporation
Microbiology
79d
Cleared
Sep 27, 2011
ISOAMP HSV ASSAY
Biohelix Corporation
Microbiology
81d
Cleared
Aug 03, 2011
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
Eragen Biosciences, Inc.
Microbiology
63d
Cleared
Mar 18, 2011
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
Becton, Dickinson & CO
Microbiology
81d