Data / Medical devices / Kit, Screening, Staphylococcus Aureus
Kit, Screening, Staphylococcus Aureus (JWX): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Kit, Screening, Staphylococcus Aureus (product code JWX, Class 1, 21 CFR 866.2660). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on December 16, 2009, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JWX
- Device class
- 1
- Regulation
- 866.2660
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| United Kingdom | 2 |
| France | 2 |
| Spain | 1 |
Makers of Kit, Screening, Staphylococcus Aureus
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 |
|---|---|---|---|---|---|---|---|---|
| Arlington Scientific, Inc. | Springville, UT, United States | Contract manufacturer, Manufacturer | 3 | October 28, 1987 | 0 | 0 | 0 | api.fda.gov |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Manufacturer, Specification developer | 1 | September 8, 1997 | 0 | 0 | 0 | api.fda.gov |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer, Manufacturer | 1 | June 1, 1995 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 1 | February 7, 1997 | 0 | 2 | 0 | api.fda.gov |
| Biomerieux France | CRAPONNE Rhone, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux SA | LA BALME LES GROTTES Isere, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux Spain | Tres Cantos Madrid(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 16, 2009. 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.