Panels › Microbiology › Product code NQX · Class 2
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Regulation 866.1640
0510(k)s in 12 months (24 all time)
0recalls in 12 months (20 all time)
14recalls that name a 510(k)
Top companies in NQX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 10 | 4 |
| Becton Dickinson & Co. | 0 | 11 |
| Bd Diagnostics (Geneohm Sciences, Inc.) | 1 | 3 |
| Roche Molecular Systems, Inc. | 2 | 1 |
| Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2 | 0 |
| Infectio Diagnostic (I.D.I.), Inc. | 2 | 0 |
| bioMerieux, Inc. | 1 | 0 |
| Eatonform Inc | 0 | 1 |
| Elitech | 1 | 0 |
| Elitechgroup Epoch Biosciences | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2024 | K243625 | Xpert MRSA/SA SSTI Cepheid® | NQX |
| Oct 25, 2024 | K243070 | Xpert® SA Nasal Complete Cepheid® | NQX |
| Sep 25, 2019 | K191742 | ARIES MRSA Assay Luminex Corporation | NQX |
| Apr 25, 2019 | K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System Cepheid | NQX |
| Nov 23, 2016 | K162444 | Xpert MRSA NxG Cepheid | NQX |
| Dec 17, 2014 | K142721 | cobas MRSA/SA Test Roche Molecular Systems, Inc. | NQX |
| Dec 20, 2013 | K133605 | BD MAX MRSA XT, BD MAX INSTRUMENT Geneohm Sciences Canada, Inc., CA | NQX |
| Nov 26, 2013 | K132822 | BD MAX STAPHSR ASSAY, INSTRUMENT Geneohm Sciences Canada, Inc. (Bd Diagnostics), CA | NQX |
| Oct 17, 2013 | K132468 | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE Elitechgroup Epoch Biosciences | NQX |
| Jun 20, 2013 | K130894 | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE Cepheid | NQX |
| Jul 5, 2012 | K120138 | BD MAX MRSA ASSAY, BD MAX INSTRUMENT Bd Diagnostics (Geneohm Sciences Canada, Inc) | NQX |
| Jun 1, 2012 | K112937 | MRSA/SA ELITE MGB Elitech | NQX |
| Dec 16, 2011 | K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) Nanosphere, Inc. | NQX |
| May 20, 2011 | K102740 | NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 bioMerieux, Inc. | NQX |
| Jul 28, 2010 | K101879 | XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 Cepheid | NQX |
| Jul 6, 2010 | K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 Roche Molecular Systems, Inc. | NQX |
| Jun 1, 2010 | K100822 | XPERT MRSA/SA NASAL ASSAY Cepheid | NQX |
| Dec 15, 2009 | K093346 | BD GENEOHM MRSA ACP ASSAY Bd Diagnostics (Geneohm Sciences, Inc.) | NQX |
| Sep 29, 2008 | K082140 | XPERT MRSA/SA BLOOD CULTURE ASSAY Cepheid | NQX |
| Sep 24, 2008 | K080837 | XPERT MRSA/SA SSTI ASSAY Cepheid | NQX |
| Dec 20, 2007 | K071026 | BD GENEOHM STAPHSR ASSAY Bd Diagnostics (Geneohm Sciences Canada, Inc) | NQX |
| Apr 17, 2007 | K070462 | XPERT MRSA Cepheid | NQX |
| Oct 22, 2004 | K042357 | IDI-MRSA ASSAY Infectio Diagnostic (I.D.I.), Inc. | NQX |
| Mar 18, 2004 | K033415 | IDI-MRSA Infectio Diagnostic (I.D.I.), Inc., CA | NQX |
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