Data / Medical devices / France / Biomerieux SA
Biomerieux SA: FDA-registered device maker in LA BALME LES GROTTES Isere, France, 69 510(k) clearances
Biomerieux SA is registered with the FDA (registration 9615754) in LA BALME LES GROTTES Isere, France. It lists 22 device types. The FDA files 69 510(k) clearances under its listings, the newest dated April 21, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9615754
- FEI number
- 3008237827
- Address
- 3 Route De Port Michaud, LA BALME LES GROTTES Isere, France, 38390
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 22, 1994
- Registered through
- 2027
- Brand names listed
- 12 SLIDES CAROUSEL, 30 SLIDES CAROUSEL, ACETONE FUCHSIN-A, ACETONE SAFRANIN-A (NA), ALBICANS ID2, AMIKACIN, API 20 C AUX, API 20 E (100) and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 21, 2026 | K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | JWY | Substantially Equivalent | bioMérieux SA | accessdata.fda.gov |
| June 12, 2025 | K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | JWY | Substantially Equivalent | Biomérieux | accessdata.fda.gov |
| April 30, 2025 | K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| October 5, 2023 | K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | JWY | Substantially Equivalent | Biomérieux | accessdata.fda.gov |
| March 15, 2022 | K212461 | VITEK MS PRIME | QBN | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 12, 2021 | K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| May 7, 2020 | K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) | JWY | Substantially Equivalent | Biomérieux SA | accessdata.fda.gov |
| November 26, 2019 | K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| September 27, 2019 | K192050 | ETEST Eravacycline (ERV) (0.002 32 µg/mL) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| August 22, 2019 | K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| May 1, 2019 | K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| January 11, 2019 | K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| December 21, 2018 | K181412 | VITEK MS | QBN | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 3, 2018 | K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| September 15, 2017 | K172150 | Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) | JWY | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 22, 2017 | K162950 | VITEK MS | PEX | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 31, 2017 | K170670 | Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) | JWY | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 27, 2017 | K162385 | RAPIDEC CARBA NP | PTJ | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| October 7, 2015 | K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | JWY | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| August 21, 2013 | DEN130013 | VITEK MS | PEX | Unknown | bioMerieux, Inc. | accessdata.fda.gov |
| October 12, 2012 | K121002 | ETEST CEFTAROLINE | JWY | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 17, 2010 | K102668 | ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML | JWY | Substantially Equivalent | BIOMERIEUX | accessdata.fda.gov |
| August 25, 2010 | K093604 | ETEST MOXIFLOXACIN 0.002-32 UG/ML | JWY | Substantially Equivalent | Ab Biomerieux | accessdata.fda.gov |
| November 2, 2009 | K082534 | ETEST VORICONAZOLE 0.002-32 UG/ML | NGZ | Substantially Equivalent | Ab Biomerieux | accessdata.fda.gov |
| July 24, 2008 | K081325 | ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| October 13, 2005 | K052366 | ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| December 13, 2004 | K042392 | DAPTOMYCIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| November 19, 2004 | K042390 | ETEST FOR GEMIFLOXACIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| July 27, 2004 | K040560 | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING | NGZ | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| April 29, 2002 | K020748 | ETEST ERTAPENEM | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| April 9, 2001 | K010363 | ETEST MEROPENEM | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| November 8, 2000 | K002139 | ETEST LINEZOLID | LTX | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| August 7, 2000 | K001547 | ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 18, 2000 | K000298 | ETEST MOXIFLOXACIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| November 16, 1999 | K992993 | ETEST FOR QUINUPRISTIN/DALFOPRISTIN | LTX | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| April 22, 1999 | K990722 | ETEST FOR CEFUROXIME | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| March 22, 1999 | K990297 | ETEST MINOCYCLINE | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| October 2, 1998 | K983027 | TRIMETHOPRIM/SULPHAMETHOXAZOLE | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| September 30, 1998 | K982868 | ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| June 9, 1998 | K981137 | ETEST CEFOTAXIME | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| June 9, 1998 | K981136 | ETEST FOSFOMYCIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| June 9, 1998 | K981135 | ETEST BENZYLPENICILLIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| June 5, 1998 | K981138 | ETEST CIPROFLOXACIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| June 1, 1998 | K981139 | ETEST CEFTRIAXONE | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 29, 1998 | K980348 | ETEST VANCOMYCIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 29, 1998 | K980342 | ETEST CHLORAMPHENICAL | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 28, 1998 | K981134 | ETEST TETRACYCLINE | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 28, 1998 | K980338 | ETEST OFLOXACIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 27, 1998 | K980345 | ETEST CEFTRIAXONE | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| July 14, 1997 | K971697 | ETEST FOR LEVOFLOXACIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| June 30, 1997 | K971694 | ETEST FOR CEFTAZIDIME | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 1, 1997 | K970473 | ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 1, 1997 | K970210 | AMIKACIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| October 24, 1996 | K963107 | ETEST FOR CEFEPIME | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| October 8, 1996 | K960991 | ETEST SUBMISSION FOR AMOXICILLIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| August 30, 1996 | K962794 | ETEST FOR AZTREONAM | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| July 5, 1996 | K961519 | ETEST SUBMISSION FOR AZITHROMYCIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 20, 1996 | K960989 | ETEST SUBMISSION FOR IMIPENEM | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| February 22, 1996 | K955920 | THE E TEST CEFTIZOXIME | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| August 15, 1995 | K953223 | PIPERACILIN TAZOBACTAM 4 UG | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| July 7, 1995 | K951879 | TICARCILLIN/CLAVULANIC ACID 2 | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| May 2, 1995 | K946364 | E TEST FOR OFLOXACIN | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| April 14, 1995 | K950328 | AMOXICILLIN/CLAVULANIC ACID 2/1 | JWY | Substantially Equivalent | Ab Biodisk North America, Inc. | accessdata.fda.gov |
| March 17, 1995 | K945433 | ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| November 4, 1994 | K935519 | ETEST FOR AMPICILLIN/SULBACTAM 2/1 | JWY | Substantially Equivalent | Ab Biodisk North America, Inc. | accessdata.fda.gov |
| February 12, 1993 | K923579 | MINIVIDAS INSTRUMENT | JJE | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| September 25, 1991 | K913459 | THE E TEST, MODIFICATION | JWY | Substantially Equivalent | Ab Biodisk | accessdata.fda.gov |
| July 26, 1991 | K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | LQL | Substantially Equivalent | Vitek Systems, Inc. | accessdata.fda.gov |
| April 18, 1989 | K891385 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) | DEW | Substantially Equivalent | Vitek Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 2, 2021 | 88658 | Class II | Terminated | MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System | Under certain conditions, there is a risk for a false negative result. | accessdata.fda.gov |
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Updated April 21, 2026. 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.