Data / Medical devices / System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (NQX): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (product code NQX, Class 2, 21 CFR 866.1640). 7 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on December 18, 2024, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NQX
- Device class
- 2
- Regulation
- 866.1640
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Canada | 1 |
| Switzerland | 1 |
Makers of System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 8 | December 18, 2024 | 0 | 4 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer, Manufacturer for export | 7 | December 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | December 20, 2013 | 0 | 4 | 0 | api.fda.gov |
| GeneOhm Sciences Canada, ULC. | Quebec, Canada | Manufacturer | 2 | December 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 2 | December 17, 2014 | 0 | 1 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 2 | December 17, 2014 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 1 | December 17, 2014 | 0 | 0 | 0 | api.fda.gov |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| VWR Chemicals, LLC | Solon, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.