bioMerieux, Inc.
bioMerieux, Inc. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2026, with 423 FDA device recalls on record.
Clearances by bioMerieux, Inc. — page 2
101–200 of 253- K093383 — NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
- K092454 — VITEK 2 YEAST VORICONAZOLE
- K091025 — CHROMID VRE AGAR, MODEL: REF 43 851
- K093224 — DENSICHECK PLUS
- K083536 — DENSICHEK PLUS
- K091899 — VITEK 2 GRAM NEGATIVE MEROPENEM
- K091024 — CHROMID MRSA AGAR, MODEL: REF 43 841
- K080469 — VIDAS CA 15-3 ASSAY
- K091126 — VITEK 2 GRAM POSITIVE DAPTOMYCIN
- K080561 — VIDAS CA 125 II ASSAY
- K082346 — VITEK 2 GRAM NEGATIVE DORIPENEM
- K083383 — VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
- K080766 — VIDAS RUB IGG
- K080194 — VIDAS CEA (S) ASSAY
- K080017 — VIDAS AFP ASSAY
- K063261 — NUCLISENS EASYQ ENTEROVIRUS SYSTEM
- K080931 — VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
- K080201 — VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
- K073091 — VIDAS NT-PROBNP ASSAY, MODEL: 30 449
- K080107 — VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
- K073406 — VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
- K072138 — VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
- K063243 — VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
- K073083 — VITEK 2 GRAM NEGATIVE PIPERACILLIN
- K072695 — VITEK 2 GRAM POSITIVE TIGECYCLINE
- K072668 — VITEK 2 GRAM POSITIVE VANCOMYCIN
- K071146 — VIDAS B.R.A.H.M.S. PCT ASSAY
- K072038 — VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
- K063597 — VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE
- K063623 — VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
- K063492 — VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
- K061945 — VITEK 2 AST-YS FLUCONAZOLE
- K061347 — VITEK 2 GRAM POSITIVE VRSA SCREEN
- K051030 — COAG-A-MATE MTX III
- K053097 — VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
- K053186 — VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
- K052656 — VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
- K052311 — VITEK 2 GRAM NEGATIVE TIGECYCLINE
- K051849 — VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
- K050976 — VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
- K050816 — VITEK 2 GRAM POSITIVE MEROPENEM
- K050513 — MDA B.30
- K050075 — VITEK 2 GRAM POSITIVE DAPTOMYCIN
- K050076 — VITEK 2 GRAM POSITIVE ERTAPENEM
- K050002 — VITEK 2 COMPACT
- K043230 — VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
- K043237 — VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
- K042963 — VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
- K042946 — VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
- K041982 — VITEK 2 GRAM NEGATIVE ERTAPENEM
- K040882 — VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
- K040845 — VITEK 2 ESBL TEST
- K032861 — VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
- K032788 — VITEK 2 GRAM NEGATIVE GATIFLOXACIN
- K032711 — VITEK GRAM NEGATIVE GATIFLOXACIN
- K032738 — VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
- K032766 — VITEK 2 GRAM POSITIVE LINEZOLID
- K032399 — VITEK 2 GRAM POSITIVE MOXIFLOXACIN
- K030328 — VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
- K032314 — VITEK 2 GRAM POSITIVE GATIFLOXACIN
- K031865 — VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
- K031737 — BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
- K031410 — VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
- K030950 — VIDAS TROPONIN I (TNI), MODEL 30 445
- K020810 — VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
- K022045 — VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
- K021877 — MDA D-DIMER
- K021326 — VIDAS TESTOSTERONE (TES), MODEL 30 418
- K021123 — BACT/ALERT SN CULTURE BOTTLE
- K020815 — BACT/ALERT FN CULTURE BOTTLE
- K020923 — BACT/ALERT PF CULTURE BOTTLE
- K020931 — BACT/ALERT SA CULTURE BOTTLE
- K020813 — BACT/ALERT FA CULTURE BOTTLE
- K020871 — VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
- K020870 — VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
- K010550 — VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
- K001460 — VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
- K993319 — VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
- K965084 — VIDAS PROESTERONE (PRG) (30 409)
- K925863 — SPUNCRIT
- K872646 — VIRON(TM)
- K871088 — ANAEROBIC LKV BLOOD AGAR
- K871089 — ANAEROBIC BLOOD AGAR (CDC FORMULATION)
- K871090 — ANAEROBIC PEA BLOOD AGAR
- K871091 — BACTEROIDES BILE ESCULIN AGAR
- K871092 — HORSE BLOOD AGAR, ENRICHED
- K871093 — CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)
- K871094 — BRILLIANT GREEN AGAR
- K871095 — CLED AGAR
- K871096 — CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
- K871097 — CHOCOLATE MUELLER HINTON AGAR
- K871098 — TRYPTIC SOY AGAR
- K844542 — CYSTINE TRYPTIC AGAR W/DEXTROSE
- K844543 — CYSTINE TRYPTIC AGAR W/LACTOSE
- K844544 — CYSTINE TRYPTIC AGAR W/MALTOSE
- K844545 — CYSTINE TRYPTIC AGAR W/MANNITOL
- K844546 — CYSTINE TRYPTIC AGAR W/SUCROSE
- K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE
- K844548 — UREA AGAR
- K844513 — V AGAR
Data sourced from openFDA. This site is unofficial and independent of the FDA.