MXJ · Class II · 21 CFR 866.3305

FDA Product Code MXJ: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Leading manufacturers include Focus Diagnostics, Inc., Focus Technologies, Inc. and Zeus Scientific, Inc..

20
Total
20
Cleared
179d
Avg days
1999
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Devices (Product Code MXJ)

20 devices
1–20 of 20
Cleared Sep 20, 2023
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
K213987
Biokit, S.A.
Microbiology · 639d
Cleared Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
K220923
Roche Diagnostics
Microbiology · 195d
Cleared Aug 23, 2018
ADVIA Centaur Herpes-1 IgG
K181333
Biokit, S.A.
Microbiology · 94d
Cleared Oct 01, 2016
SeraQuest Herpes Type 1 Specific IgG
K162276
Quest International, Inc.
Microbiology · 50d
Cleared Jul 02, 2015
Theranos Herpes Simplex Virus-1 IgG Assay
K143236
Theranos, Inc.
Microbiology · 232d
Cleared Feb 28, 2014
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
K131334
Gold Standard Diagnostics
Microbiology · 295d
Cleared Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K120625
Roche Diagnostics
Microbiology · 146d
Cleared Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
K120959
Bio-Rad Laboratories
Microbiology · 84d
Cleared Apr 26, 2011
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
K103363
Zeus Scientific, Inc.
Microbiology · 160d
Cleared May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K090409
Bio-Rad Laboratories
Microbiology · 79d
Cleared Nov 18, 2008
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
K081685
DiaSorin, Inc.
Microbiology · 154d
Cleared May 30, 2008
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
K072178
Zeus Scientific, Inc.
Microbiology · 298d
Cleared Oct 05, 2007
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
K071511
Focus Diagnostics, Inc.
Microbiology · 123d
Cleared Sep 24, 2007
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
K071510
Focus Diagnostics, Inc.
Microbiology · 112d
Cleared Feb 01, 2007
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
K062543
Focus Diagnostics, Inc.
Microbiology · 155d
Cleared Jul 13, 2004
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
K033105
Trinity Biotech USA
Microbiology · 287d
Cleared Aug 01, 2002
HERPESELECT 2 ELISA IGG, MODEL ELO920G
K021486
Focus Technologies, Inc.
Microbiology · 90d
Cleared Jul 29, 2002
HERPESELECT 1 ELISA IGG, MODEL EL0910G
K021429
Focus Technologies, Inc.
Microbiology · 87d
Cleared Feb 09, 2000
HSV-1 ELISA IGG, MODEL EL0910G
K993754
Mrl Diagnostics
Microbiology · 96d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K984343
Meridian Diagnostics, Inc.
Microbiology · 203d

About Product Code MXJ - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code MXJ since 1999, with 20 receiving FDA clearance (average review time: 179 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.