Atlas FDA

PGX

14 FDA 510(k) clearances · Product code

92 daysmedian time to decision
181 days90th percentile
14clearances measured

FDA profile

Official device name
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Device class
Class II (moderate risk)
Regulation
21 CFR 866.2680
Medical specialty
Microbiology
FDA definition
An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.
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RecordFirmDate
LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (K260333)Diasorin Molecular, LLC2026-06-15
Accula Strep A Test (K201269)Mesa Biotech, Inc.2020-11-09
GenePOC Strep A (K183366)Genepoc, Inc.2019-03-06
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (K173653)Alere Scarborough, Inc.2018-05-02
Xpert Xpress Strep A (K173398)Cepheid2018-04-26
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (K172402)Luminex Corporation2017-10-30
Xpert Xpress Strep A (K172126)Cepheid2017-09-25
Solana Strep Complete Assay (K162274)Quidel Corporation2016-10-25
Solana GAS Assay, Solana instrument (K150868)Quidel Corporation2015-06-23
ALERE I STREP A (K141757)Alere Scarborough, Inc.2015-03-31
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (K143651)Focus Diagnostics, Inc.2015-03-18
LIAT STREP A ASSAY (K141338)Iquum, Inc.2014-11-04
AMPLIVUE GAS ASSAY (K141173)Quidel Corporation2014-07-24
LYRA DIRECT STREP ASSAY (DEN140005)Quidel Corporation2014-04-16

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Every clearance here is in the API, with alerts when new ones post.