FDA Product Code MXJ: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Leading manufacturers include Roche Diagnostics and Biokit, S.A..
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
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.
MXJ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →