FDA Product Code MXJ: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Leading manufacturers include Zeus Scientific, Inc., Bio-Rad Laboratories and Roche Diagnostics.
20
Total
20
Cleared
179d
Avg days
1999
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Devices (Product Code MXJ)
20 devices
Cleared
Sep 20, 2023
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
Biokit, S.A.
Microbiology
639d
Cleared
Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
Roche Diagnostics
Microbiology
195d
Cleared
Aug 23, 2018
ADVIA Centaur Herpes-1 IgG
Biokit, S.A.
Microbiology
94d
Cleared
Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
Roche Diagnostics
Microbiology
146d
Cleared
Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
Bio-Rad Laboratories
Microbiology
84d
Cleared
Apr 26, 2011
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
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
Bio-Rad Laboratories
Microbiology
79d
Cleared
Nov 18, 2008
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
DiaSorin, Inc.
Microbiology
154d
Cleared
May 30, 2008
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
Zeus Scientific, Inc.
Microbiology
298d
Cleared
Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
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 2 in the prior period.