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Panels › Microbiology › Product code PGI · Class 2

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

Regulation 866.3309

0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in PGI

Company510(k)sRecalls
Diasorin Molecular, LLC21
Luminex Corporation11
Quidel Corporation20
Abbott Molecular, Inc.10
Diagnostic Hybrids, Inc.10
Elitechgroup10
Meridian Bioscience, Inc.10
Decided510(k)Device and applicantCode
May 3, 2024K233349Alinity m HSV 1 & 2 / VZV
Abbott Molecular, Inc.
PGI
Dec 20, 2023K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
Quidel Corporation
PGI
Nov 26, 2019K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
Diasorin Molecular, LLC
PGI
Oct 29, 2018K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
Elitechgroup
PGI
Mar 14, 2018K173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Diasorin Molecular, LLC
PGI
Nov 28, 2016K162451Solana HSV 1+2/VZV Assay
Quidel Corporation
PGI
Oct 6, 2015K151906ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cas
Luminex Corporation
PGI
Jul 17, 2015K151046illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
Meridian Bioscience, Inc.
PGI
May 13, 2014DEN140004QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
Diagnostic Hybrids, Inc.
PGI

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