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bioMerieux, Inc.

253 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG (K093383)bioMerieux, Inc.2010-07-06
VITEK 2 YEAST VORICONAZOLE (K092454)bioMerieux, Inc.2010-05-21
CHROMID VRE AGAR, MODEL: REF 43 851 (K091025)bioMerieux, Inc.2010-03-02
DENSICHECK PLUS (K093224)bioMerieux, Inc.2009-11-09
DENSICHEK PLUS (K083536)bioMerieux, Inc.2009-09-11
VITEK 2 GRAM NEGATIVE MEROPENEM (K091899)bioMerieux, Inc.2009-08-14
CHROMID MRSA AGAR, MODEL: REF 43 841 (K091024)bioMerieux, Inc.2009-07-17
VIDAS CA 15-3 ASSAY (K080469)bioMerieux, Inc.2009-06-22
VITEK 2 GRAM POSITIVE DAPTOMYCIN (K091126)bioMerieux, Inc.2009-06-18
VIDAS CA 125 II ASSAY (K080561)bioMerieux, Inc.2009-04-10
VITEK 2 GRAM NEGATIVE DORIPENEM (K082346)bioMerieux, Inc.2009-03-16
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K083383)bioMerieux, Inc.2009-02-18
VIDAS RUB IGG (K080766)bioMerieux, Inc.2008-12-23
VIDAS CEA (S) ASSAY (K080194)bioMerieux, Inc.2008-10-09
VIDAS AFP ASSAY (K080017)bioMerieux, Inc.2008-09-26
NUCLISENS EASYQ ENTEROVIRUS SYSTEM (K063261)bioMerieux, Inc.2008-06-23
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (K080931)bioMerieux, Inc.2008-06-11
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE (K080201)bioMerieux, Inc.2008-04-30
VIDAS NT-PROBNP ASSAY, MODEL: 30 449 (K073091)bioMerieux, Inc.2008-02-29
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM (K080107)bioMerieux, Inc.2008-02-28
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE (K073406)bioMerieux, Inc.2008-01-23
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (K072138)bioMerieux, Inc.2007-12-21
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 (K063243)bioMerieux, Inc.2007-12-14
VITEK 2 GRAM NEGATIVE PIPERACILLIN (K073083)bioMerieux, Inc.2007-12-10
VITEK 2 GRAM POSITIVE TIGECYCLINE (K072695)bioMerieux, Inc.2007-11-16
VITEK 2 GRAM POSITIVE VANCOMYCIN (K072668)bioMerieux, Inc.2007-10-15
VIDAS B.R.A.H.M.S. PCT ASSAY (K071146)bioMerieux, Inc.2007-10-11
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN (K072038)bioMerieux, Inc.2007-09-12
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE (K063597)bioMerieux, Inc.2007-01-19
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE (K063623)bioMerieux, Inc.2007-01-11
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K063492)bioMerieux, Inc.2006-12-21
VITEK 2 AST-YS FLUCONAZOLE (K061945)bioMerieux, Inc.2006-09-19
VITEK 2 GRAM POSITIVE VRSA SCREEN (K061347)bioMerieux, Inc.2006-06-20
COAG-A-MATE MTX III (K051030)bioMerieux, Inc.2005-12-23
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN (K053097)bioMerieux, Inc.2005-12-14
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K053186)bioMerieux, Inc.2005-12-01
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN (K052656)bioMerieux, Inc.2005-11-07
VITEK 2 GRAM NEGATIVE TIGECYCLINE (K052311)bioMerieux, Inc.2005-09-29
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE (K051849)bioMerieux, Inc.2005-08-16
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE (K050976)bioMerieux, Inc.2005-05-23
VITEK 2 GRAM POSITIVE MEROPENEM (K050816)bioMerieux, Inc.2005-05-12
MDA B.30 (K050513)bioMerieux, Inc.2005-04-01
VITEK 2 GRAM POSITIVE DAPTOMYCIN (K050075)bioMerieux, Inc.2005-02-28
VITEK 2 GRAM POSITIVE ERTAPENEM (K050076)bioMerieux, Inc.2005-02-18
VITEK 2 COMPACT (K050002)bioMerieux, Inc.2005-02-17
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM (K043230)bioMerieux, Inc.2004-12-30
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN (K043237)bioMerieux, Inc.2004-12-23
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM (K042963)bioMerieux, Inc.2004-12-13
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN (K042946)bioMerieux, Inc.2004-12-07
VITEK 2 GRAM NEGATIVE ERTAPENEM (K041982)bioMerieux, Inc.2004-09-14
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 (K040882)bioMerieux, Inc.2004-06-10
VITEK 2 ESBL TEST (K040845)bioMerieux, Inc.2004-06-08
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN (K032861)bioMerieux, Inc.2003-11-12
VITEK 2 GRAM NEGATIVE GATIFLOXACIN (K032788)bioMerieux, Inc.2003-11-04
VITEK 2 GRAM POSITIVE LINEZOLID (K032766)bioMerieux, Inc.2003-10-31
VITEK GRAM NEGATIVE GATIFLOXACIN (K032711)bioMerieux, Inc.2003-10-31
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN (K032738)bioMerieux, Inc.2003-10-31
VITEK 2 GRAM POSITIVE MOXIFLOXACIN (K032399)bioMerieux, Inc.2003-09-10
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 (K030328)bioMerieux, Inc.2003-09-02
VITEK 2 GRAM POSITIVE GATIFLOXACIN (K032314)bioMerieux, Inc.2003-08-22
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE (K031865)bioMerieux, Inc.2003-08-13
BACT/ALERT MP CULTURE BOTTLES (PLASTIC) (K031737)bioMerieux, Inc.2003-07-14
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE (K031410)bioMerieux, Inc.2003-07-10
VIDAS TROPONIN I (TNI), MODEL 30 445 (K030950)bioMerieux, Inc.2003-06-16
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 (K020810)bioMerieux, Inc.2002-10-03
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID (K022045)bioMerieux, Inc.2002-08-15
MDA D-DIMER (K021877)bioMerieux, Inc.2002-08-07
VIDAS TESTOSTERONE (TES), MODEL 30 418 (K021326)bioMerieux, Inc.2002-07-18
BACT/ALERT SN CULTURE BOTTLE (K021123)bioMerieux, Inc.2002-04-26
BACT/ALERT FN CULTURE BOTTLE (K020815)bioMerieux, Inc.2002-04-18
BACT/ALERT PF CULTURE BOTTLE (K020923)bioMerieux, Inc.2002-04-18
BACT/ALERT SA CULTURE BOTTLE (K020931)bioMerieux, Inc.2002-04-18
BACT/ALERT FA CULTURE BOTTLE (K020813)bioMerieux, Inc.2002-04-17
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN (K020871)bioMerieux, Inc.2002-03-29
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN (K020870)bioMerieux, Inc.2002-03-25
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (K010550)bioMerieux, Inc.2001-04-24
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 (K001460)bioMerieux, Inc.2000-10-04
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 (K993319)bioMerieux, Inc.2000-05-22
VIDAS PROESTERONE (PRG) (30 409) (K965084)bioMerieux, Inc.1997-01-09
SPUNCRIT (K925863)bioMerieux, Inc.1993-02-05
VIRON(TM) (K872646)bioMerieux, Inc.1987-09-14
CHOCOLATE MUELLER HINTON AGAR (K871097)bioMerieux, Inc.1987-04-03
ANAEROBIC BLOOD AGAR (CDC FORMULATION) (K871089)bioMerieux, Inc.1987-04-03
CLED AGAR (K871095)bioMerieux, Inc.1987-04-03
CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR) (K871093)bioMerieux, Inc.1987-04-03
ANAEROBIC LKV BLOOD AGAR (K871088)bioMerieux, Inc.1987-04-03
ANAEROBIC PEA BLOOD AGAR (K871090)bioMerieux, Inc.1987-04-03
CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES (K871096)bioMerieux, Inc.1987-04-03
BACTEROIDES BILE ESCULIN AGAR (K871091)bioMerieux, Inc.1987-04-03
BRILLIANT GREEN AGAR (K871094)bioMerieux, Inc.1987-04-03
HORSE BLOOD AGAR, ENRICHED (K871092)bioMerieux, Inc.1987-04-03
TRYPTIC SOY AGAR (K871098)bioMerieux, Inc.1987-04-03
TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (K844547)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/DEXTROSE (K844542)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/LACTOSE (K844543)bioMerieux, Inc.1985-01-16
UREA AGAR (K844548)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/MALTOSE (K844544)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/SUCROSE (K844546)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/MANNITOL (K844545)bioMerieux, Inc.1985-01-16
COOKED MEAT MEDIUM (K844538)bioMerieux, Inc.1985-01-07
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