FDA 510(k) Applications Submitted by BIOMERIEUX, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K993319 |
10/04/1999 |
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 |
BIOMERIEUX, INC. |
K141149 |
05/05/2014 |
VITEK 2 AST GP CEFTAROLINE |
BIOMERIEUX, INC. |
K133952 |
12/23/2013 |
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE |
BIOMERIEUX, INC. |
K151923 |
07/13/2015 |
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) |
BIOMERIEUX, INC. |
K170670 |
03/06/2017 |
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) |
bioMerieux, Inc. |
K190616 |
03/11/2019 |
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 ╡g/mL) |
bioMerieux, Inc. |
K172944 |
09/26/2017 |
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ╡g/mL |
bioMerieux, Inc. |
K193299 |
11/27/2019 |
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 ╡g/mL) |
BioMerieux, Inc. |
K183415 |
12/10/2018 |
VITEK 2 AST-Gram Negative Imipenem (=0.25->= 16 ug/mL) |
bioMerieux, Inc. |
K183551 |
12/20/2018 |
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) |
bioMerieux, Inc. |
K201675 |
06/19/2020 |
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 ╡g/mL) |
bioMerieux, Inc. |
K202396 |
08/21/2020 |
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) |
bioMerieux, Inc. |
K213931 |
12/16/2021 |
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 ╡g/mL) |
bioMerieux, Inc. |
K121446 |
05/15/2012 |
BACT/ALERT PF PLUS CULTURE BOTTLE |
BIOMERIEUX, INC. |
K121863 |
06/26/2012 |
VITEK 2 AST-ST CEFOTAXIME |
BIOMERIEUX, INC. |
K122547 |
08/21/2012 |
GRAM POSTITVE CLINDAMYCIN |
BIOMERIEUX, INC. |
K113783 |
12/22/2011 |
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K190405 |
02/19/2019 |
BACT/ALERT MP Reagent System |
bioMerieux, Inc. |
K191766 |
07/01/2019 |
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4╡g/mL) |
bioMerieux, Inc. |
K222378 |
08/05/2022 |
VITEK 2 AST-Gram Negative Levofloxacin (=0.125 ->/=8 ug/mL) |
bioMerieux, Inc. |
K172731 |
09/11/2017 |
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) |
bioMerieux, Inc. |
K213241 |
09/30/2021 |
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole |
BioMerieux, Inc. |
K213899 |
12/14/2021 |
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin |
bioMerieux, Inc. |
K183524 |
12/19/2018 |
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) |
bioMerieux, Inc. |
K193567 |
12/23/2019 |
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 û >=16 ug/mL) |
BioMerieux, Inc. |
K001460 |
05/10/2000 |
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 |
BIOMERIEUX, INC. |
K121002 |
04/02/2012 |
ETEST CEFTAROLINE |
BIOMERIEUX, INC. |
K121546 |
05/25/2012 |
VITEK 2 GRAM NEGATIVE DOXYCYCLINE |
BIOMERIEUX, INC. |
K111976 |
07/12/2011 |
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN |
BIOMERIEUX, INC. |
K112228 |
08/03/2011 |
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN |
BIOMERIEUX, INC. |
K181412 |
05/30/2018 |
VITEK MS |
bioMerieux, Inc. |
K163006 |
10/28/2016 |
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) |
bioMerieux, Inc. |
K151688 |
06/23/2015 |
chromID MRSA |
bioMerieux, Inc. |
K050513 |
03/01/2005 |
MDA B.30 |
BIOMERIEUX, INC. |
K121100 |
04/11/2012 |
VITEK 2 AST STREPTOCOCUS VANCOMYCIN |
BIOMERIEUX, INC. |
K121461 |
05/17/2012 |
BACT/ALERT FA PLUS CULTURE BOTTLE |
BIOMERIEUX, INC. |
K031737 |
06/04/2003 |
BACT/ALERT MP CULTURE BOTTLES (PLASTIC) |
BIOMERIEUX, INC. |
K102740 |
09/22/2010 |
NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 |
BIOMERIEUX, INC. |
K133817 |
12/16/2013 |
VITEK 2 AST - YEAST FLUCONAZOLE |
BIOMERIEUX, INC. |
K051030 |
04/22/2005 |
COAG-A-MATE MTX III |
BIOMERIEUX, INC. |
K063492 |
11/17/2006 |
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K072038 |
07/25/2007 |
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN |
BIOMERIEUX, INC. |
K050075 |
01/12/2005 |
VITEK 2 GRAM POSITIVE DAPTOMYCIN |
BIOMERIEUX, INC. |
K050076 |
01/12/2005 |
VITEK 2 GRAM POSITIVE ERTAPENEM |
BIOMERIEUX, INC. |
K110106 |
01/13/2011 |
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE |
BIOMERIEUX, INC. |
K080201 |
01/28/2008 |
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE |
BIOMERIEUX, INC. |
K050816 |
03/31/2005 |
VITEK 2 GRAM POSITIVE MEROPENEM |
BIOMERIEUX, INC. |
K091126 |
04/20/2009 |
VITEK 2 GRAM POSITIVE DAPTOMYCIN |
BIOMERIEUX, INC. |
K181368 |
05/23/2018 |
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 ╡g/mL) |
bioMerieux, Inc. |
K161816 |
07/01/2016 |
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO |
bioMerieux, Inc. |
K111893 |
07/05/2011 |
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE |
BIOMERIEUX, INC. |
K112000 |
07/13/2011 |
VITEK 2 STREPTOCOCCUS PENICILLIN |
BIOMERIEUX, INC. |
K112075 |
07/20/2011 |
VITEK 2 STRPTOCOCCUS AMPICILLIN |
BIOMERIEUX, INC. |
K112129 |
07/26/2011 |
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN |
BIOMERIEUX, INC. |
K082346 |
08/15/2008 |
VITEK 2 GRAM NEGATIVE DORIPENEM |
BIOMERIEUX, INC. |
K052311 |
08/24/2005 |
VITEK 2 GRAM NEGATIVE TIGECYCLINE |
BIOMERIEUX, INC. |
K072668 |
09/21/2007 |
VITEK 2 GRAM POSITIVE VANCOMYCIN |
BIOMERIEUX, INC. |
K072695 |
09/24/2007 |
VITEK 2 GRAM POSITIVE TIGECYCLINE |
BIOMERIEUX, INC. |
K052656 |
09/26/2005 |
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN |
BIOMERIEUX, INC. |
K093076 |
09/30/2009 |
VITEK 2 GRAM POSITIVE DOXCYCLINE |
BIOMERIEUX, INC. |
K093224 |
10/14/2009 |
DENSICHECK PLUS |
BIOMERIEUX, INC. |
K042946 |
10/26/2004 |
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN |
BIOMERIEUX, INC. |
K042963 |
10/27/2004 |
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM |
BIOMERIEUX, INC. |
K113305 |
11/09/2011 |
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
K083383 |
11/17/2008 |
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K043230 |
11/22/2004 |
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM |
BIOMERIEUX, INC. |
K043237 |
11/22/2004 |
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN |
BIOMERIEUX, INC. |
K083536 |
11/28/2008 |
DENSICHEK PLUS |
BIOMERIEUX, INC. |
K063597 |
12/04/2006 |
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K063623 |
12/06/2006 |
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K103752 |
12/23/2010 |
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE |
BIOMERIEUX, INC. |
K193572 |
12/23/2019 |
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 ╡g/mL) |
BioMerieux, Inc. |
K161217 |
04/29/2016 |
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) |
bioMerieux, Inc. |
K161437 |
05/24/2016 |
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) |
BIOMERIEUX, INC. |
K162076 |
07/27/2016 |
chromID MRSA |
bioMerieux, Inc. |
K163042 |
10/31/2016 |
chromID Strepto B agar |
bioMerieux, Inc. |
K021326 |
04/26/2002 |
VIDAS TESTOSTERONE (TES), MODEL 30 418 |
BIOMERIEUX, INC. |
K093383 |
10/30/2009 |
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG |
BIOMERIEUX, INC. |
K101946 |
07/12/2010 |
VIDAS TOXO IGG AVIDITY |
BIOMERIEUX, INC. |
K183166 |
11/15/2018 |
BacT/ALERT FA Plus; BacT/ALERT PF Plus |
bioMerieux, Inc. |
K163083 |
11/03/2016 |
VITEK 2 AST-GN Tobramycin (=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (=1->/=16 ug/mL) |
bioMerieux, Inc. |
DEN130013 |
01/02/2013 |
VITEK MS |
BIOMERIEUX, INC. |
K050002 |
01/03/2005 |
VITEK 2 COMPACT |
BIOMERIEUX, INC. |
K080107 |
01/15/2008 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM |
BIOMERIEUX, INC. |
K010550 |
02/26/2001 |
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 |
BIOMERIEUX, INC. |
K030950 |
03/26/2003 |
VIDAS TROPONIN I (TNI), MODEL 30 445 |
BIOMERIEUX, INC. |
K040845 |
04/01/2004 |
VITEK 2 ESBL TEST |
BIOMERIEUX, INC. |
K091024 |
04/10/2009 |
CHROMID MRSA AGAR, MODEL: REF 43 841 |
BIOMERIEUX, INC. |
K091025 |
04/10/2009 |
CHROMID VRE AGAR, MODEL: REF 43 851 |
BIOMERIEUX, INC. |
K050976 |
04/18/2005 |
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
K031410 |
05/05/2003 |
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K061347 |
05/15/2006 |
VITEK 2 GRAM POSITIVE VRSA SCREEN |
BIOMERIEUX, INC. |
K101566 |
06/04/2010 |
VITEK 2 YEAST CASPOFUNGIN |
BIOMERIEUX, INC. |
K031865 |
06/17/2003 |
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K022045 |
06/24/2002 |
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID |
BIOMERIEUX, INC. |
K091899 |
06/25/2009 |
VITEK 2 GRAM NEGATIVE MEROPENEM |
BIOMERIEUX, INC. |
K051849 |
07/07/2005 |
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K061945 |
07/10/2006 |
VITEK 2 AST-YS FLUCONAZOLE |
BIOMERIEUX, INC. |
K041982 |
07/23/2004 |
VITEK 2 GRAM NEGATIVE ERTAPENEM |
BIOMERIEUX, INC. |
K032314 |
07/28/2003 |
VITEK 2 GRAM POSITIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
K032399 |
08/04/2003 |
VITEK 2 GRAM POSITIVE MOXIFLOXACIN |
BIOMERIEUX, INC. |
K092454 |
08/10/2009 |
VITEK 2 YEAST VORICONAZOLE |
BIOMERIEUX, INC. |
K032711 |
09/02/2003 |
VITEK GRAM NEGATIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
K032738 |
09/04/2003 |
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN |
BIOMERIEUX, INC. |
K032766 |
09/05/2003 |
VITEK 2 GRAM POSITIVE LINEZOLID |
BIOMERIEUX, INC. |
K032788 |
09/08/2003 |
VITEK 2 GRAM NEGATIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
K032861 |
09/12/2003 |
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN |
BIOMERIEUX, INC. |
K073083 |
11/01/2007 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN |
BIOMERIEUX, INC. |
K053097 |
11/03/2005 |
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN |
BIOMERIEUX, INC. |
K053186 |
11/14/2005 |
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
K073406 |
12/04/2007 |
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
K020871 |
12/28/2001 |
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN |
BIOMERIEUX, INC. |
K020870 |
12/28/2001 |
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN |
BIOMERIEUX, INC. |
K111599 |
06/08/2011 |
VITEK 2 AST-ST LINEZOLID |
BIOMERIEUX, INC. |
K131779 |
06/17/2013 |
VITEK 2 AST-ST TIGECYCLINE |
BIOMERIEUX, INC. |
K111909 |
07/05/2011 |
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE |
BIOMERIEUX, INC. |
K212461 |
08/06/2021 |
VITEK MS PRIME |
bioMerieux, Inc. |
K132507 |
08/12/2013 |
VITEK 2 AST ST MEROPENEM |
BIOMERIEUX, INC. |
K132573 |
08/16/2013 |
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN |
BIOMERIEUX, INC. |
K162950 |
10/24/2016 |
VITEK MS |
bioMerieux, Inc. |
K080017 |
01/03/2008 |
VIDAS AFP ASSAY |
BIOMERIEUX, INC. |
K080194 |
01/25/2008 |
VIDAS CEA (S) ASSAY |
BIOMERIEUX, INC. |
K080469 |
02/21/2008 |
VIDAS CA 15-3 ASSAY |
BIOMERIEUX, INC. |
K080766 |
03/18/2008 |
VIDAS RUB IGG |
BIOMERIEUX, INC. |
K080931 |
04/02/2008 |
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY |
BIOMERIEUX, INC. |
K071146 |
04/24/2007 |
VIDAS B.R.A.H.M.S. PCT ASSAY |
BIOMERIEUX, INC. |
K072138 |
08/02/2007 |
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 |
BIOMERIEUX, INC. |
K063243 |
10/26/2006 |
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 |
BIOMERIEUX, INC. |
K073091 |
11/01/2007 |
VIDAS NT-PROBNP ASSAY, MODEL: 30 449 |
BIOMERIEUX, INC. |
K121455 |
05/16/2012 |
BACT/ALERT FN PLUS CULTURE BOTTLE |
BIOMERIEUX, INC. |
K020813 |
03/13/2002 |
BACT/ALERT FA CULTURE BOTTLE |
BIOMERIEUX, INC. |
K020815 |
03/13/2002 |
BACT/ALERT FN CULTURE BOTTLE |
BIOMERIEUX, INC. |
K020923 |
03/21/2002 |
BACT/ALERT PF CULTURE BOTTLE |
BIOMERIEUX, INC. |
K020931 |
03/22/2002 |
BACT/ALERT SA CULTURE BOTTLE |
BIOMERIEUX, INC. |
K021123 |
04/08/2002 |
BACT/ALERT SN CULTURE BOTTLE |
BIOMERIEUX, INC. |
K021877 |
06/07/2002 |
MDA D-DIMER |
BIOMERIEUX, INC. |
K030328 |
01/31/2003 |
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 |
BIOMERIEUX, INC. |
K020810 |
03/13/2002 |
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 |
BIOMERIEUX, INC. |
K040882 |
04/05/2004 |
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 |
BIOMERIEUX, INC. |
K063261 |
10/30/2006 |
NUCLISENS EASYQ ENTEROVIRUS SYSTEM |
BIOMERIEUX, INC. |
K113200 |
10/31/2011 |
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM |
BIOMERIEUX, INC. |
K080561 |
02/28/2008 |
VIDAS CA 125 II ASSAY |
BIOMERIEUX, INC. |
K965084 |
12/19/1996 |
VIDAS PROESTERONE (PRG) (30 409) |
BIOMERIEUX, INC. |
K122359 |
08/03/2012 |
VITEK 2 STRPTOCOCCUS CEFTRIAXONE |
BIOMERIEUX, INC. |
K112818 |
09/28/2011 |
VIDAS D-DIMER EXCLUSION II (DEX2) |
BIOMERIEUX, INC. |
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