Product code OQO

Device name: Herpes Simplex Virus Nucleic Acid Amplification Assay
Medical specialty: Microbiology
Device class: 2
Regulation number: 866.3305
Review panel: MI
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K172509	Sentosa SA201 HSV 1/2 Qualitative PCR Test	Vela Diagnostics USA, Inc.	2018-02-01
K162673	Aptima Herpes Simplex Viruses 1 & 2 Assay	Hologic, Inc.	2017-06-15
K150962	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	Focus Diagnostics	2015-08-28
K150617	cobas HSV 1 and 2 Test	Roche Molecular Systems, Inc.	2015-06-01
K142156	SEEGENE ANYPLEX II HSV-1/2 ASSAY	Seegene	2015-02-13
K142738	artus HSV-1/2 QS-RGQ MDx Kit	Qiagen	2014-12-19
K140198	IMDX HSV-1/2 FOR ABBOTT M2000	Intelligent Medical Devices, Inc.	2014-05-13
K140029	AMIPLIVUE HSV 1&2 ASSAY	Quidel Corporation	2014-03-26
K111951	ISOAMP HSV ASSAY	Biohelix Corporation	2011-09-27
K111527	MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT	Eragen Biosciences, Inc.	2011-08-03
K103798	BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS	Becton, Dickinson & CO	2011-03-18
K100336	MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711	Eragen Biosciences	2010-05-12

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08885013953664	Sentosa SA201 HSV-1/2 PCR Test	VELA OPERATIONS SINGAPORE PTE. LTD.	2018-04-16
25420045510187	Aptima®	Hologic, Inc.	2018-01-16
15420045507210	Aptima®	Hologic, Inc.	2017-06-23
15420045507227	Aptima®	Hologic, Inc.	2017-06-23
15420045507234	Aptima®	Hologic, Inc.	2017-06-23
25420045507248	Aptima®	Hologic, Inc.	2017-02-16
04053228004660	artus® HSV-1/2 QS-RGQ MDx Kit	QIAGEN GmbH	2017-01-04
00875197004434	cobas® 4800 System Lysis Kit	Roche Molecular Systems, Inc.	2016-09-24
00875197004458	cobas® 4800 Systems Internal Control Kit	Roche Molecular Systems, Inc.	2016-09-24
00875197005264	cobas® 4800 System Lysis Kit	Roche Molecular Systems, Inc.	2016-09-24
20816101025507	Simplexa™ HSV 1 & 2 Direct	DIASORIN MOLECULAR LLC	2016-09-22
20816101025514	Simplexa™ HSV 1 & 2 Positive Control Pack	DIASORIN MOLECULAR LLC	2016-09-22
30014613312109	AmpliVue	QUIDEL CORPORATION	2016-09-15
00840487101032	Mutlicode®-RTx HSV 1&2 Kit	LUMINEX CORPORATION	2016-09-09
00382904417482	Control Set for the BD ProbeTec™ Herpes Simplex Viruses	BECTON, DICKINSON AND COMPANY	2016-07-07
00382904417499	BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack	BECTON, DICKINSON AND COMPANY	2016-07-07

Related 510(k) Records#