PGI · Class II · 21 CFR 866.3309

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 and Abbott Molecular, Inc..

9
Total
8
Cleared
124d
Avg days
2014
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples Devices (Product Code PGI)

9 devices
1–9 of 9
Cleared May 03, 2024
Alinity m HSV 1 & 2 / VZV
K233349
Abbott Molecular, Inc.
Microbiology · 217d
Cleared Dec 20, 2023
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
K232286
Quidel Corporation
Microbiology · 141d

About Product Code PGI - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code PGI since 2014, with 8 receiving FDA clearance (average review time: 124 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

PGI devices are reviewed by the Microbiology panel. Browse all Microbiology devices →