FDA 510(k) Applications for Medical Device Product Code "NQX"
(System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K071026 | BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) | BD GENEOHM STAPHSR ASSAY | 12/20/2007 |
| K120138 | BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) | BD MAX MRSA ASSAY, BD MAX INSTRUMENT | 07/05/2012 |
| K093346 | BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) | BD GENEOHM MRSA ACP ASSAY | 12/15/2009 |
| K102740 | BIOMERIEUX, INC. | NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 | 05/20/2011 |
| K070462 | CEPHEID | XPERT MRSA | 04/17/2007 |
| K162444 | CEPHEID | Xpert MRSA NxG | 11/23/2016 |
| K101879 | CEPHEID | XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 | 07/28/2010 |
| K082140 | CEPHEID | XPERT MRSA/SA BLOOD CULTURE ASSAY | 09/29/2008 |
| K130894 | CEPHEID | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE | 06/20/2013 |
| K190771 | Cepheid | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | 04/25/2019 |
| K100822 | CEPHEID | XPERT MRSA/SA NASAL ASSAY | 06/01/2010 |
| K080837 | CEPHEID | XPERT MRSA/SA SSTI ASSAY | 09/24/2008 |
| K112937 | ELITECH | MRSA/SA ELITE MGB | 06/01/2012 |
| K132468 | ELITechGroup Epoch Biosciences | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE | 10/17/2013 |
| K133605 | GENEOHM SCIENCES CANADA, INC. | BD MAX MRSA XT, BD MAX INSTRUMENT | 12/20/2013 |
| K132822 | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | BD MAX STAPHSR ASSAY, INSTRUMENT | 11/26/2013 |
| K033415 | INFECTIO DIAGNOSTIC (I.D.I.) INC. | IDI-MRSA | 03/18/2004 |
| K042357 | INFECTIO DIAGNOSTIC (I.D.I.) INC. | IDI-MRSA ASSAY | 10/22/2004 |
| K191742 | Luminex Corporation | ARIES MRSA Assay | 09/25/2019 |
| K112424 | NANOSPHERE, INC | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | 12/16/2011 |
| K142721 | ROCHE MOLECULAR SYSTEMS, INC. | cobas MRSA/SA Test | 12/17/2014 |
| K091409 | ROCHE MOLECULAR SYSTEMS, INC. | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 | 07/06/2010 |
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