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Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Regulation 866.2680

2510(k)s in 12 months (15 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in PGX

Company510(k)sRecalls
Cepheid22
Quidel Corporation40
Alere Scarborough, Inc.20
Focus Diagnostics, Inc.11
Luminex Corporation11
Diasorin Molecular, LLC10
Genepoc, Inc.10
Iquum, Inc.10
Mesa Biotech, Inc.10
Roche Molecular Systems, Inc.10
Decided510(k)Device and applicantCode
Aug 28, 2026K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402
Roche Molecular Systems, Inc.
PGX
Jun 15, 2026K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
Diasorin Molecular, LLC
PGX
Nov 9, 2020K201269Accula Strep A Test
Mesa Biotech, Inc.
PGX
Mar 6, 2019K183366GenePOC Strep A
Genepoc, Inc., CA
PGX
May 2, 2018K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Alere Scarborough, Inc.
PGX
Apr 26, 2018K173398Xpert Xpress Strep A
Cepheid
PGX
Oct 30, 2017K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Luminex Corporation
PGX
Sep 25, 2017K172126Xpert Xpress Strep A
Cepheid
PGX
Oct 25, 2016K162274Solana Strep Complete Assay
Quidel Corporation
PGX
Jun 23, 2015K150868Solana GAS Assay, Solana instrument
Quidel Corporation
PGX
Mar 31, 2015K141757ALERE I STREP A
Alere Scarborough, Inc.
PGX
Mar 18, 2015K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
Focus Diagnostics, Inc.
PGX
Nov 4, 2014K141338LIAT STREP A ASSAY
Iquum, Inc.
PGX
Jul 24, 2014K141173AMPLIVUE GAS ASSAY
Quidel Corporation
PGX
Apr 16, 2014DEN140005LYRA DIRECT STREP ASSAY
Quidel Corporation
PGX

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