FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K120959 |
Bio-Rad Laboratories |
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT |
06/22/2012 |
K090409 |
Bio-Rad Laboratories |
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
05/08/2009 |
K181333 |
Biokit, S.A. |
ADVIA Centaur Herpes-1 IgG |
08/23/2018 |
K213987 |
Biokit, S.A. |
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls |
09/20/2023 |
K081685 |
DIASORIN, INC. |
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG |
11/18/2008 |
K062543 |
FOCUS DIAGNOSTICS, INC. |
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G |
02/01/2007 |
K071510 |
FOCUS DIAGNOSTICS, INC. |
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 |
09/24/2007 |
K071511 |
FOCUS DIAGNOSTICS, INC. |
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G |
10/05/2007 |
K021429 |
FOCUS TECHNOLOGIES, INC. |
HERPESELECT 1 ELISA IGG, MODEL EL0910G |
07/29/2002 |
K021486 |
FOCUS TECHNOLOGIES, INC. |
HERPESELECT 2 ELISA IGG, MODEL ELO920G |
08/01/2002 |
K131334 |
GOLD STANDARD DIAGNOSTICS |
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST |
02/28/2014 |
K984343 |
MERIDIAN DIAGNOSTICS, INC. |
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST |
06/25/1999 |
K993754 |
MRL DIAGNOSTICS |
HSV-1 ELISA IGG, MODEL EL0910G |
02/09/2000 |
K162276 |
QUEST INTERNATIONAL, INC |
SeraQuest Herpes Type 1 Specific IgG |
10/01/2016 |
K220923 |
Roche Diagnostics |
Elecsys HSV-1 IgG (08948844160) |
10/12/2022 |
K120625 |
Roche Diagnostics |
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV |
07/25/2012 |
K143236 |
THERANOS, INC. |
Theranos Herpes Simplex Virus-1 IgG Assay |
07/02/2015 |
K033105 |
TRINITY BIOTECH USA |
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT |
07/13/2004 |
K072178 |
ZEUS SCIENTIFIC, INC. |
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM |
05/30/2008 |
K103363 |
ZEUS SCIENTIFIC, INC. |
ZEUS ELISA HSV GC-I IGG TEST SYSTEM |
04/26/2011 |