Company · US
Biomerieux Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2026. Name variants (Inc, Corp, punctuation) are merged.
275510(k) clearances (4 in 12 months)
635recalls (4 in 12 months)
234recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 308 |
| N/A | 144 | |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 64 |
| MDB | System, Blood Culturing | 64 |
| LTW | Susceptibility Test Cards, Antimicrobial | 39 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 20 |
| JSJ | Culture Media, Selective And Non-Differential | 18 |
| NGZ | Susceptibility Test Plate, Antifungal | 14 |
| JSG | Culture Media, Non-Selective And Non-Differential | 13 |
| JSI | Culture Media, Selective And Differential | 13 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 13 |
| JSH | Culture Media, Non-Selective And Differential | 12 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 7 |
| JSF | Culture Media, Single Biochemical Test | 7 |
| PPM | General Purpose Reagent | 7 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 6 |
| JST | Kit, Fastidious Organisms | 6 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 6 |
| LQL | Gram Positive Identification Panel | 6 |
| GJS | Test, Time, Prothrombin | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2026 | K260283 | VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) bioMerieux, Inc. | LON |
| Jul 8, 2026 | K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System bioMerieux, Inc. | SAN |
| Apr 15, 2026 | K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance bioMerieux, Inc. | LON |
| Mar 26, 2026 | K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) BIOMERIEUX | LON |
| Aug 21, 2025 | K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) bioMerieux, Inc. | LON |
| Apr 30, 2025 | K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) Biomerieux S.A., FR | JWY |
| Mar 14, 2025 | K234012 | VITEK COMPACT PRO bioMerieux, Inc. | LON |
| Jun 12, 2024 | K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) bioMerieux, Inc. | NGZ |
| Jun 7, 2024 | K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) bioMerieux, Inc. | NGZ |
| May 1, 2024 | K240279 | VIDAS TBI (GFAP, UCH-L1) bioMerieux, Inc. | QAT |
| Mar 11, 2024 | K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) bioMerieux, Inc. | LON |
| Oct 23, 2023 | K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK bioMerieux, Inc. | LON |
| Jul 5, 2023 | K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-G bioMerieux, Inc. | LON |
| Jun 26, 2023 | K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) bioMerieux, Inc. | LON |
| Mar 9, 2023 | K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Biomerieux Sa, Inc. | LON |
| Feb 16, 2023 | K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST- bioMerieux, Inc. | LON |
| Feb 9, 2023 | K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) bioMerieux, Inc. | LON |
| Feb 3, 2023 | K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) bioMerieux, Inc. | LON |
| Jan 27, 2023 | K220803 | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST- bioMerieux, Inc. | LON |
| Oct 13, 2022 | K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen bioMerieux, Inc. | LON |
| Aug 8, 2022 | K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) bioMerieux, Inc. | LON |
| Jul 12, 2022 | K213899 | VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST- bioMerieux, Inc. | LON |
| Jun 3, 2022 | K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) bioMerieux, Inc. | LON |
| Apr 14, 2022 | K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) bioMerieux, Inc. | LON |
| Mar 15, 2022 | K212461 | VITEK MS PRIME bioMerieux, Inc. | QBN |
| Feb 25, 2022 | K213241 | VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconaz bioMerieux, Inc. | LON |
| Nov 12, 2021 | K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) Biomerieux S.A., FR | JWY |
| Oct 28, 2021 | K210287 | VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) bioMerieux, Inc. | LON |
| Sep 14, 2021 | K202396 | VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) bioMerieux, Inc. | LON |
| Aug 30, 2021 | K211630 | VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) bioMerieux, Inc. | LON |
| Jul 9, 2021 | K201675 | VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) bioMerieux, Inc. | LON |
| Jun 14, 2021 | K211136 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) bioMerieux, Inc. | LON |
| Sep 28, 2020 | K193299 | VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) bioMerieux, Inc. | LON |
| Apr 28, 2020 | K200590 | VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) bioMerieux, Inc. | LON |
| Mar 13, 2020 | K193572 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) bioMerieux, Inc. | LON |
| Feb 14, 2020 | K193567 | VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL) bioMerieux, Inc. | LON |
| Nov 26, 2019 | K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) Biomerieux S.A., FR | JWY |
| Oct 31, 2019 | K192110 | Vitek Densichek bioMerieux, Inc. | LON |
| Sep 27, 2019 | K192050 | ETEST Eravacycline (ERV) (0.002 32 µg/mL) Biomerieux S.A., FR | JWY |
| Aug 22, 2019 | K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) Biomerieux S.A., FR | JWY |
| Aug 5, 2019 | K191766 | VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) bioMerieux, Inc. | LON |
| Jun 6, 2019 | K190616 | VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) bioMerieux, Inc. | LON |
| May 15, 2019 | K190405 | BACT/ALERT MP Reagent System bioMerieux, Inc. | MDB |
| May 1, 2019 | K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) Biomerieux S.A., FR | JWY |
| Mar 12, 2019 | K183524 | VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) bioMerieux, Inc. | LON |
| Mar 7, 2019 | K183551 | VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) bioMerieux, Inc. | LON |
| Feb 26, 2019 | K183360 | VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) bioMerieux, Inc. | LON |
| Feb 20, 2019 | K183415 | VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) bioMerieux, Inc. | LON |
| Feb 11, 2019 | K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus bioMerieux, Inc. | MDB |
| Jan 11, 2019 | K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) Biomerieux S.A., FR | JWY |
Newest 50 of 275.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | BioMerieux SA EMAG system
Model/Catalog Number: 418591/418591U
Product Description: Nucleic acid sample preparation instrument IVD, automated Open, Classified |
JJH | None listed |
| Sep 18, 2026 | Biomerieux Inc VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 Open, Classified |
LON | None listed |
| Jul 9, 2026 | Biomerieux Inc VITEK 2 AST-N447 TEST KIT
Product reference 424620 Open, Classified |
LON | None listed |
| Feb 2, 2026 | Biomerieux Inc VITEK 2 Gram-negative Susceptibility Cards Containing
o Polymyxin B (pb02n)
o Ceftazidime/avibactam (cza02n)
o Meropenem/Vaborbactam (mev01n)
o Imipenem (ipm05n)
o Imipenem/Relebactam (ipr01n);
CARD Open, Classified |
LTW | K172944 K183360 +3 |
| Sep 29, 2025 | bioMerieux, Inc. VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n.
VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification Open, Classified |
LON | None listed |
| Apr 25, 2024 | Biomerieux Inc VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility):
a) AST-N334, REF 418984;
b) AST-GN95, REF 421982;
c) AST-GN99, REF 423102;
d) AST-N390, REF 423340;
e) Open, Classified |
LON | K161217 |
| Mar 2, 2023 | Biomerieux Inc MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (L Open, Classified |
OUG | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035 Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065 Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040 Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100 Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 Open, Classified |
NTM | K071146 |
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 Open, Classified |
CHP | K955647 |
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01 Open, Classified |
JLS | None listed |
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01 Open, Classified |
CEP | K921176 |
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01 Open, Classified |
LYR | K141133 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 Open, Classified |
LON | K152075 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 Open, Classified |
JWY | K980348 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786 Open, Classified |
JWY | K010363 |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723 Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425 Open, Classified |
LTW | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 Open, Classified |
LTW | None listed |
| Jan 4, 2023 | Biomerieux Inc GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105 Open, Classified |
LSM | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 Open, Classified |
JWY | K181031 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553 Open, Classified |
JWY | K192050 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 Open, Classified |
JWY | K191953 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 Open, Classified |
LON | K121100 |
| Jan 4, 2023 | Biomerieux Inc PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751 Open, Classified |
PQZ | K163042 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046 Open, Classified |
JWY | K172150 |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014 Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049 Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670 Open, Classified |
LON | K032399 |
| Jan 4, 2023 | Biomerieux Inc PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524 Open, Classified |
JSO | K162076 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 Open, Classified |
JWY | K170670 |
| Jan 4, 2023 | Biomerieux Inc GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 Open, Classified |
NVQ | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012 Open, Classified |
JSO | K181092 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438 Open, Classified |
LON | K041982 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437 Open, Classified |
LON | K040845 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 Open, Classified |
LON | K040485 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401 Open, Classified |
LON | None listed |
Newest 50 of 635.