Data / Medical devices / France / Biomerieux France
Biomerieux France: FDA-registered device maker in CRAPONNE Rhone, France, 5 510(k) clearances
Biomerieux France is registered with the FDA (registration 9615755) in CRAPONNE Rhone, France. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 6, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9615755
- FEI number
- 3007808629
- Address
- 5 Rue De Acqueducs, CRAPONNE Rhone, France, 69290
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 25, 1992
- Registered through
- 2027
- Brand names listed
- ALBICANS ID2, API 20 C AUX, API 20 E (100), API 20 E (25), API 20 NE, API 20 STREP, API CAMPY, API CORYNE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | JSO | 2 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Selective And Differential | JSI | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Selective Broth | JSD | 1 | Manufacturer | accessdata.fda.gov |
| Discs, Strips And Reagents, Microorganism Differentiation | JTO | 1 | Manufacturer | accessdata.fda.gov |
| Gbs Culture Media, Selective And Differential | PQZ | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Identification, Enterobacteriaceae | JSS | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Identification, Yeast | JXB | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Screening, Staphylococcus Aureus | JWX | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Screening, Urine | JXA | 1 | Manufacturer | accessdata.fda.gov |
| Stains, Dye Solution | LEE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 6, 2018 | K181092 | CHROMID CARBA agar (CARB) | JSO | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| January 27, 2017 | K163042 | chromID Strepto B agar | PQZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 11, 2016 | K151688 | chromID MRSA | JSO | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 2, 2010 | K091025 | CHROMID VRE AGAR, MODEL: REF 43 851 | JSO | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 17, 2009 | K091024 | CHROMID MRSA AGAR, MODEL: REF 43 841 | JSO | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- All makers of Discs, Strips And Reagents, Microorganism Differentiation
- All makers of Kit, Identification, Enterobacteriaceae
- All makers of Culture Media, Non-Selective And Non-Differential
- All makers of Kit, Screening, Urine
- All makers of Kit, Identification, Yeast
Updated July 6, 2018. 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.