Atlas FDA

NQX

24 FDA 510(k) clearances · Product code

80 daysmedian time to decision
242 days90th percentile
24clearances measured

FDA profile

Official device name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Medical specialty
Microbiology
FDA definition
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
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RecordFirmDate
Xpert MRSA/SA SSTI (K243625)Cepheid®2024-12-18
Xpert® SA Nasal Complete (K243070)Cepheid®2024-10-25
ARIES MRSA Assay (K191742)Luminex Corporation2019-09-25
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K190771)Cepheid2019-04-25
Xpert MRSA NxG (K162444)Cepheid2016-11-23
cobas MRSA/SA Test (K142721)Roche Molecular Systems, Inc.2014-12-17
BD MAX MRSA XT, BD MAX INSTRUMENT (K133605)Geneohm Sciences Canada, Inc.2013-12-20
BD MAX STAPHSR ASSAY, INSTRUMENT (K132822)Geneohm Sciences Canada, Inc. (Bd Diagnostics)2013-11-26
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE (K132468)Elitechgroup Epoch Biosciences2013-10-17
XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE (K130894)Cepheid2013-06-20
BD MAX MRSA ASSAY, BD MAX INSTRUMENT (K120138)Bd Diagnostics (Geneohm Sciences Canada, Inc)2012-07-05
MRSA/SA ELITE MGB (K112937)Elitech2012-06-01
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) (K112424)Nanosphere, Inc.2011-12-16
NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 (K102740)bioMerieux, Inc.2011-05-20
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 (K101879)Cepheid2010-07-28
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 (K091409)Roche Molecular Systems, Inc.2010-07-06
XPERT MRSA/SA NASAL ASSAY (K100822)Cepheid2010-06-01
BD GENEOHM MRSA ACP ASSAY (K093346)Bd Diagnostics (Geneohm Sciences, Inc.)2009-12-15
XPERT MRSA/SA BLOOD CULTURE ASSAY (K082140)Cepheid2008-09-29
XPERT MRSA/SA SSTI ASSAY (K080837)Cepheid2008-09-24
BD GENEOHM STAPHSR ASSAY (K071026)Bd Diagnostics (Geneohm Sciences Canada, Inc)2007-12-20
XPERT MRSA (K070462)Cepheid2007-04-17
IDI-MRSA ASSAY (K042357)Infectio Diagnostic (I.D.I.), Inc.2004-10-22
IDI-MRSA (K033415)Infectio Diagnostic (I.D.I.), Inc.2004-03-18

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