510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PGIClass II

Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

21 CFR 866.3309 / Microbiology
FDA source (opens on fda.gov)

PGI is the FDA product code for Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples, a class II device type, regulated under 21 CFR 866.3309. FDA's definition for this code reads: "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". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PGI
Device name
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
FDA definition
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.
Regulation
21 CFR 866.3309
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
2

Clearances, product code PGI

By decision year
9 clearances under product code PGI with a decision year between 2014 and 2024, 2015 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PGI by decision year
YearClearances
20141
20152
20161
20182
20191
20231
20241

Applicants with the most clearances

Product code PGI
Applicants holding the most 510(k) clearances under product code PGI
ApplicantClearances
Ortho-Clinical Diagnostics, Inc.3
DiaSorin Molecular LLC2
Abbott Molecular, Inc.1
ELITechGroup Inc1
Luminex Corporation1
Meridian Bioscience Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code