Herpes Simplex Virus Nucleic Acid Amplification Assay
Microbiology · 21 CFR 866.3305
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.
Recent MDR events
9 adverse event reports on file
- HSV-1 & HSV-2Apr 30, 2025MalfunctionUnkMW5169629
- MY LAB BOX HSV 2 TEST KITApr 19, 2024MalfunctionUnkMW5153978
- HSV 2 VAGINAL PCR SWABFeb 7, 2024MalfunctionUnkMW5151179
- SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACKMay 18, 2016MalfunctionFocus Diagnostics2023365-2016-00045
- SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACKMar 10, 2016MalfunctionFocus Diagnostics2023365-2016-00031
- SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACKMar 10, 2016MalfunctionFocus Diagnostics2023365-2016-00033
- SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACKMar 10, 2016MalfunctionFocus Diagnostics2023365-2016-00035
- SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACKMar 6, 2016MalfunctionFocus Diagnostics2023365-2016-00011
- SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACKMar 6, 2016MalfunctionFocus Diagnostics2023365-2016-00018
Event type breakdown
Most-reported manufacturers
Registered firms
7 firms currently registered for this product code
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Roche Molecular Systems, Inc.
PLEASANTON, CA, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Diasorin Molecular Llc
CYPRESS, CA, US
Hologic, Inc.
SAN DIEGO, CA, US
Vela Operations Singapore Pte Ltd
Singapore Central Singapore, SG
510(k) clearances
12 clearances for this product code
- Vela Diagnostics USA, Inc.Feb 1, 2018
K172509 · Sentosa SA201 HSV 1/2 Qualitative PCR Test
- Hologic, Inc.Jun 15, 2017
K162673 · Aptima Herpes Simplex Viruses 1 & 2 Assay
- Focus DiagnosticsAug 28, 2015
K150962 · Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- Roche Molecular Systems, Inc.Jun 1, 2015
K150617 · cobas HSV 1 and 2 Test
- SeegeneFeb 13, 2015
K142156 · SEEGENE ANYPLEX II HSV-1/2 ASSAY
- QiagenDec 19, 2014
K142738 · artus HSV-1/2 QS-RGQ MDx Kit
- Intelligent Medical Devices, Inc.May 13, 2014
K140198 · IMDX HSV-1/2 FOR ABBOTT M2000
- Quidel CorporationMar 26, 2014
K140029 · AMIPLIVUE HSV 1&2 ASSAY