FDA 510(k) Applications for Medical Device Product Code "MXJ"
(Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1)

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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact