bioMerieux, Inc.

250 FDA 510(k) medical device clearances.

Recent clearances by bioMerieux, Inc.

1–100 of 250

K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) LON · 2025-08-21
K234012 — VITEK COMPACT PRO LON · 2025-03-14
K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) NGZ · 2024-06-12
K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) NGZ · 2024-06-07
K240279 — VIDAS TBI (GFAP, UCH-L1) QAT · 2024-05-01
K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) LON · 2024-03-11
K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin LON · 2023-10-23
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-GP Daptomycin LON · 2023-07-05
K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) LON · 2023-06-26
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-GN Plazomicin LON · 2023-02-16
K222073 — VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) LON · 2023-02-09
K223481 — VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) LON · 2023-02-03
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-GP Moxifloxacin LON · 2023-01-27
K220805 — VITEK 2 AST-Gram Positive Cefoxitin Screen LON · 2022-10-13
K212243 — VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) LON · 2022-08-08
K213899 — VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin LON · 2022-07-12
K213931 — VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) LON · 2022-06-03
K214023 — VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) LON · 2022-04-14
K212461 — VITEK MS PRIME QBN · 2022-03-15
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 Fluconazole LON · 2022-02-25
K210287 — VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) LON · 2021-10-28
K202396 — VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) LON · 2021-09-14
K211630 — VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) LON · 2021-08-30
K201675 — VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) LON · 2021-07-09
K211136 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) LON · 2021-06-14
K193299 — VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) LON · 2020-09-28
K200590 — VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) LON · 2020-04-28
K193572 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) LON · 2020-03-13
K193567 — VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL) LON · 2020-02-14
K192110 — Vitek Densichek LON · 2019-10-31
K191766 — VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) LON · 2019-08-05
K190616 — VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) LON · 2019-06-06
K190405 — BACT/ALERT MP Reagent System MDB · 2019-05-15
K183524 — VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) LON · 2019-03-12
K183551 — VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) LON · 2019-03-07
K183360 — VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) LON · 2019-02-26
K183415 — VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) LON · 2019-02-20
K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus MDB · 2019-02-11
K181412 — VITEK MS QBN · 2018-12-21
K181766 — VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance LON · 2018-12-10
K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) NGZ · 2018-06-20
K172944 — VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL LON · 2017-12-19
K172731 — VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) LON · 2017-12-08
K172150 — Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) JWY · 2017-09-15
K162950 — VITEK MS PEX · 2017-07-22
K162737 — VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) LON · 2017-06-21
K170670 — Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) JWY · 2017-05-31
K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO MDB · 2017-03-28
K163563 — VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL) LON · 2017-03-13
K162827 — VIDAS B.R.A.H.M.S. PCT (PCT) PRI · 2017-02-23
K161437 — VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) LON · 2017-02-16
K161510 — VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) LON · 2017-02-13
K163083 — VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) LON · 2017-02-01
K163042 — chromID Strepto B agar PQZ · 2017-01-27
K163006 — VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) LON · 2017-01-24
K161217 — VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) LON · 2017-01-12
K162076 — chromID MRSA JSO · 2016-10-25
K161227 — VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) LON · 2016-07-20
K160911 — VIDAS B.R.A.H.M.S. PCT (PCT) PMT · 2016-06-28
K152075 — VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) LON · 2016-04-15
K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) NGZ · 2016-03-25
K151688 — chromID MRSA JSO · 2016-03-11
K151817 — VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL NGZ · 2016-02-18
K133952 — VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE NGZ · 2014-08-19
K133817 — VITEK 2 AST - YEAST FLUCONAZOLE NGZ · 2014-08-05
K141149 — VITEK 2 AST GP CEFTAROLINE LON · 2014-06-20
K132507 — VITEK 2 AST ST MEROPENEM LON · 2013-11-15
K131779 — VITEK 2 AST-ST TIGECYCLINE LON · 2013-10-10
K132573 — VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN LON · 2013-09-13
DEN130013 — VITEK MS PEX · 2013-08-21
K121446 — BACT/ALERT PF PLUS CULTURE BOTTLE MDB · 2013-01-25
K121455 — BACT/ALERT FN PLUS CULTURE BOTTLE MDB · 2013-01-25
K121461 — BACT/ALERT FA PLUS CULTURE BOTTLE MDB · 2013-01-22
K121546 — VITEK 2 GRAM NEGATIVE DOXYCYCLINE LON · 2012-11-20
K121100 — VITEK 2 AST STREPTOCOCUS VANCOMYCIN LON · 2012-11-19
K122547 — GRAM POSTITVE CLINDAMYCIN LON · 2012-10-15
K121002 — ETEST CEFTAROLINE JWY · 2012-10-12
K122359 — VITEK 2 STRPTOCOCCUS CEFTRIAXONE LON · 2012-08-28
K121863 — VITEK 2 AST-ST CEFOTAXIME LON · 2012-08-16
K113783 — VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE LON · 2012-08-07
K112818 — VIDAS D-DIMER EXCLUSION II (DEX2) DAP · 2012-07-31
K113200 — VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM LON · 2012-06-29
K111893 — VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE LON · 2012-02-28
K111976 — VITEK 2 STREPTOCOCCUS ERYTHROMYCIN LON · 2012-02-17
K113305 — VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE LON · 2012-02-10
K110106 — VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE LON · 2011-11-30
K112000 — VITEK 2 STREPTOCOCCUS PENICILLIN LON · 2011-10-26
K111909 — VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE LON · 2011-10-18
K103752 — VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE LON · 2011-10-14
K112228 — VITEK 2 STREPTOCOCCUS LEVOFLOXACIN LON · 2011-10-03
K112129 — VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN LON · 2011-09-27
K112075 — VITEK 2 STRPTOCOCCUS AMPICILLIN LON · 2011-09-15
K111599 — VITEK 2 AST-ST LINEZOLID LON · 2011-08-12
K102740 — NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 NQX · 2011-05-20
K101946 — VIDAS TOXO IGG AVIDITY LGD · 2011-05-18
K093076 — VITEK 2 GRAM POSITIVE DOXCYCLINE LON · 2010-10-21
K101566 — VITEK 2 YEAST CASPOFUNGIN NGZ · 2010-09-28
K093383 — NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG OOI · 2010-07-06
K092454 — VITEK 2 YEAST VORICONAZOLE NGZ · 2010-05-21
K091025 — CHROMID VRE AGAR, MODEL: REF 43 851 JSO · 2010-03-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Top product codes for bioMerieux, Inc.

Recent clearances by bioMerieux, Inc.