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, Diasorin Molecular, LLC and Elitechgroup.
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
Cleared
May 03, 2024
Alinity m HSV 1 & 2 / VZV
Abbott Molecular, Inc.
Microbiology
217d
Cleared
Dec 20, 2023
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
Quidel Corporation
Microbiology
141d
Cleared
Nov 26, 2019
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
Diasorin Molecular, LLC
Microbiology
88d
Cleared
Oct 29, 2018
HSV 1 & 2 ELITe MGB Kit
Elitechgroup
Microbiology
242d
Cleared
Mar 14, 2018
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Diasorin Molecular, LLC
Microbiology
90d
Cleared
Nov 28, 2016
Solana HSV 1+2/VZV Assay
Quidel Corporation
Microbiology
88d
Cleared
Jul 17, 2015
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
Meridian Bioscience, Inc.
Microbiology
88d
Not Cleared
May 13, 2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
Diagnostic Hybrids, Inc.
Microbiology
81d
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.