FDA Product Code PGI: Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
For The Qualitative Detection And Differentiation Of Vzv, Hsv1, Hsv2- Dna In Cutaneous And Mucocutaneous Lesion Samples From Symptomatic Patients. The Assay Is Not Intended For Use With Cerebral Spinal Fluid.
Leading manufacturers include Quidel Corporation.
List of Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples devices (product code PGI). 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 →