FDA Product Code MXJ: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Leading manufacturers include Biokit, S.A. and Roche Diagnostics.
2
Total
2
Cleared
417d
Avg days
2022
Since
List of Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 devices cleared through 510(k)
2 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
How to use this database
This page lists all FDA 510(k) submissions for Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 devices (product code MXJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →