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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2025 | Cepheid Xpert SA Nasal Complete
Catalog Number: GXSACOMP-10
UDI-DI code: 07332940000158
Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used f Open, Classified |
NQX | K100822 K243070 |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max MRSA XT;
Catalog # 443461 Terminated |
NQX | K133605 |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max StaphSR;
Catalog # 443419 Terminated |
NQX | K132822 |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max StaphSR;
Catalog # 443418 Terminated |
NQX | K132822 |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max MRSA;
Catalog # 442953 Terminated |
NQX | K120138 |
| Oct 27, 2017 | Roche Molecular Systems, Inc. Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic. Terminated |
NQX | K142721 |
| Jul 18, 2016 | Cepheid Xpert MRSA
Catalog GXMRSA-120, Rev. AJ
Microbiology:
The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System
(Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detec Terminated |
NQX | K070462 |
| Sep 10, 2014 | Becton Dickinson & Co. The BD MAX MRSA Assay, catalogue #442953.
An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in pati Terminated |
NQX | K120138 |
| Sep 6, 2012 | Becton Dickinson & Co. BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***
BD GeneOhm MRSA ACP Assay is Terminated |
NQX | K093346 |
| Jan 11, 2012 | Cepheid Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001; Terminated |
NQX | K082140 K101879 |
| Sep 16, 2011 | Becton Dickinson & Co. BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the numb Terminated |
NQX | None listed |
| Sep 16, 2011 | Becton Dickinson & Co. BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode sample preparation reagent tubes. The BD MAX RNA Extraction Kit is used with the BD MAX System to extract RNA from Terminated |
NQX | None listed |
| Sep 16, 2011 | Becton Dickinson & Co. BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM), Catalog Number 437503. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DN Terminated |
NQX | None listed |
| Sep 16, 2011 | Becton Dickinson & Co. BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D barcode sample preparation reagent tubes *** For use with the BD MAX System ***to extract DNA from Gram-negativ Terminated |
NQX | None listed |
| Sep 16, 2011 | Becton Dickinson & Co. BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negativ Terminated |
NQX | None listed |
| Jul 1, 2010 | Cepheid Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA.
Medical device, qualitative in vitro diagnostic test intended for the detection Terminated |
NQX | K082140 |
| Sep 10, 2009 | BD Diagnostics (GeneOhm Sciences, Inc) BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit).
For the rapid detection of methicillin resistant MRSA DNA in nasal specimen. Terminated |
NQX | K042357 |
| Oct 31, 2008 | BD Diagnostics (GeneOhm Sciences, Inc) BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) t Terminated |
NQX | K042357 |
| Oct 31, 2008 | BD Diagnostics (GeneOhm Sciences, Inc) BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) Terminated |
NQX | K042357 |
| Nov 16, 2006 | Eatonform Inc Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton. Terminated |
NQX | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.