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bioMerieux, Inc.

253 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K260160)bioMerieux, Inc.2026-07-08
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282)bioMerieux, Inc.2026-04-15
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579)bioMerieux, Inc.2025-08-21
VITEK COMPACT PRO (K234012)bioMerieux, Inc.2025-03-14
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (K232967)bioMerieux, Inc.2024-06-12
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (K232963)bioMerieux, Inc.2024-06-07
VIDAS TBI (GFAP, UCH-L1) (K240279)bioMerieux, Inc.2024-05-01
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000)bioMerieux, Inc.2024-03-11
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (K232201)bioMerieux, Inc.2023-10-23
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 (K230864)bioMerieux, Inc.2023-07-05
VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) (K222378)bioMerieux, Inc.2023-06-26
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 (K223478)bioMerieux, Inc.2023-02-16
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (K222073)bioMerieux, Inc.2023-02-09
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) (K223481)bioMerieux, Inc.2023-02-03
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 (K220803)bioMerieux, Inc.2023-01-27
VITEK 2 AST-Gram Positive Cefoxitin Screen (K220805)bioMerieux, Inc.2022-10-13
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) (K212243)bioMerieux, Inc.2022-08-08
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 (K213899)bioMerieux, Inc.2022-07-12
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) (K213931)bioMerieux, Inc.2022-06-03
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) (K214023)bioMerieux, Inc.2022-04-14
VITEK MS PRIME (K212461)bioMerieux, Inc.2022-03-15
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 (K213241)bioMerieux, Inc.2022-02-25
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) (K212849)Biomérieux, Inc.2022-02-04
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) (K210287)bioMerieux, Inc.2021-10-28
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) (K202396)bioMerieux, Inc.2021-09-14
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) (K211630)bioMerieux, Inc.2021-08-30
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) (K201675)bioMerieux, Inc.2021-07-09
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) (K211136)bioMerieux, Inc.2021-06-14
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) (K193299)bioMerieux, Inc.2020-09-28
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) (K200590)bioMerieux, Inc.2020-04-28
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) (K193572)bioMerieux, Inc.2020-03-13
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) (K193567)bioMerieux, Inc.2020-02-14
Vitek Densichek (K192110)bioMerieux, Inc.2019-10-31
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) (K191766)bioMerieux, Inc.2019-08-05
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) (K190616)bioMerieux, Inc.2019-06-06
BACT/ALERT MP Reagent System (K190405)bioMerieux, Inc.2019-05-15
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) (K183524)bioMerieux, Inc.2019-03-12
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) (K183551)bioMerieux, Inc.2019-03-07
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL) (K183360)bioMerieux, Inc.2019-02-26
VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) (K183415)bioMerieux, Inc.2019-02-20
BacT/ALERT FA Plus; BacT/ALERT PF Plus (K183166)bioMerieux, Inc.2019-02-11
VITEK MS (K181412)bioMerieux, Inc.2018-12-21
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance (K181766)bioMerieux, Inc.2018-12-10
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (K181368)bioMerieux, Inc.2018-06-20
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL (K172944)bioMerieux, Inc.2017-12-19
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) (K172731)bioMerieux, Inc.2017-12-08
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) (K172150)bioMerieux, Inc.2017-09-15
VITEK MS (K162950)bioMerieux, Inc.2017-07-22
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) (K162737)bioMerieux, Inc.2017-06-21
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) (K170670)bioMerieux, Inc.2017-05-31
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (K161816)bioMerieux, Inc.2017-03-28
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL) (K163563)bioMerieux, Inc.2017-03-13
VIDAS B.R.A.H.M.S. PCT (PCT) (K162827)bioMerieux, Inc.2017-02-23
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) (K161437)bioMerieux, Inc.2017-02-16
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) (K161510)bioMerieux, Inc.2017-02-13
VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) (K163083)bioMerieux, Inc.2017-02-01
chromID Strepto B agar (K163042)bioMerieux, Inc.2017-01-27
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) (K163006)bioMerieux, Inc.2017-01-24
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) (K161217)bioMerieux, Inc.2017-01-12
chromID MRSA (K162076)bioMerieux, Inc.2016-10-25
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) (K161227)bioMerieux, Inc.2016-07-20
VIDAS B.R.A.H.M.S. PCT (PCT) (K160911)bioMerieux, Inc.2016-06-28
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) (K152075)bioMerieux, Inc.2016-04-15
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (K151923)bioMerieux, Inc.2016-03-25
chromID MRSA (K151688)bioMerieux, Inc.2016-03-11
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (K151817)bioMerieux, Inc.2016-02-18
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (K133952)bioMerieux, Inc.2014-08-19
VITEK 2 AST - YEAST FLUCONAZOLE (K133817)bioMerieux, Inc.2014-08-05
VITEK 2 AST GP CEFTAROLINE (K141149)bioMerieux, Inc.2014-06-20
VITEK 2 AST ST MEROPENEM (K132507)bioMerieux, Inc.2013-11-15
VITEK 2 AST-ST TIGECYCLINE (K131779)bioMerieux, Inc.2013-10-10
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN (K132573)bioMerieux, Inc.2013-09-13
VITEK MS (DEN130013)bioMerieux, Inc.2013-08-21
BACT/ALERT FN PLUS CULTURE BOTTLE (K121455)bioMerieux, Inc.2013-01-25
BACT/ALERT PF PLUS CULTURE BOTTLE (K121446)bioMerieux, Inc.2013-01-25
BACT/ALERT FA PLUS CULTURE BOTTLE (K121461)bioMerieux, Inc.2013-01-22
VITEK 2 GRAM NEGATIVE DOXYCYCLINE (K121546)bioMerieux, Inc.2012-11-20
VITEK 2 AST STREPTOCOCUS VANCOMYCIN (K121100)bioMerieux, Inc.2012-11-19
GRAM POSTITVE CLINDAMYCIN (K122547)bioMerieux, Inc.2012-10-15
ETEST CEFTAROLINE (K121002)bioMerieux, Inc.2012-10-12
VITEK 2 STRPTOCOCCUS CEFTRIAXONE (K122359)bioMerieux, Inc.2012-08-28
VITEK 2 AST-ST CEFOTAXIME (K121863)bioMerieux, Inc.2012-08-16
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE (K113783)bioMerieux, Inc.2012-08-07
VIDAS D-DIMER EXCLUSION II (DEX2) (K112818)bioMerieux, Inc.2012-07-31
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM (K113200)bioMerieux, Inc.2012-06-29
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE (K111893)bioMerieux, Inc.2012-02-28
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN (K111976)bioMerieux, Inc.2012-02-17
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE (K113305)bioMerieux, Inc.2012-02-10
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE (K110106)bioMerieux, Inc.2011-11-30
VITEK 2 STREPTOCOCCUS PENICILLIN (K112000)bioMerieux, Inc.2011-10-26
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE (K111909)bioMerieux, Inc.2011-10-18
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE (K103752)bioMerieux, Inc.2011-10-14
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN (K112228)bioMerieux, Inc.2011-10-03
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN (K112129)bioMerieux, Inc.2011-09-27
VITEK 2 STRPTOCOCCUS AMPICILLIN (K112075)bioMerieux, Inc.2011-09-15
VITEK 2 AST-ST LINEZOLID (K111599)bioMerieux, Inc.2011-08-12
NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 (K102740)bioMerieux, Inc.2011-05-20
VIDAS TOXO IGG AVIDITY (K101946)bioMerieux, Inc.2011-05-18
VITEK 2 GRAM POSITIVE DOXCYCLINE (K093076)bioMerieux, Inc.2010-10-21
VITEK 2 YEAST CASPOFUNGIN (K101566)bioMerieux, Inc.2010-09-28
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