FDA Product Code MYF: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Leading manufacturers include Roche Diagnostics and Biokit, S.A..
2
Total
2
Cleared
140d
Avg days
2022
Since
List of Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 devices cleared through 510(k)
2 devices
Cleared
Feb 12, 2025
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
Biokit, S.A.
Microbiology
85d
Cleared
Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
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-2 devices (product code MYF). 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 →