FDA.reportPublic FDA data

BIOMERIEUX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14504051450405BIOMERIEUX, INC.1N2026-01-011105 N Main St LOMBARD IL US 60148
19502041950204BIOMERIEUX, INC.1Y2026-01-01595 ANGLUM RD. HAZELWOOD MO US 63042
30027697063002769706BIOMERIEUX, INC.1N2026-01-01100 RODOLPHE ST DURHAM NC US 27712
30257756673025775667BIOMERIEUX, INC.1N2026-01-011201 S 4800 W Salt Lake City UT US 84104
30319771343031977134bioMerieux, Inc.1N2026-01-013015 Carrington Mill Blvd Morrisville NC US 27560

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
97591564096010N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDLTW1978-03-02
3308671564096010N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDLTW1978-03-02
3421701564096010N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDLTW1978-03-02
97591719697936K981736BACT/ALERT 3D MICROBIAL DETECTION SYSTEMMDB1998-07-24
3308671719697936K981736BACT/ALERT 3D MICROBIAL DETECTION SYSTEMMDB1998-07-24
97591368307575K962609GRAM NEGATIVE IDENTIFICATION PLUS CARDLRH1996-08-30
97561067684892K933939BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERTGIM1994-02-07
97591825208256K910666VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATIONJSP1991-04-03
97592035124959K910304RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIALQL1991-07-26
97591668132539K903505BACT/ALERT (TM)MDB1991-03-12
3308671668132539K903505BACT/ALERT (TM)MDB1991-03-12
97591332586277K881925VITEK YEAST BIOCHEMICAL CARDJXB1988-06-16
97591563916653K260619
97591593912752K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON2026-04-15
97591673548259K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON2026-03-26
97591782890459K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN2026-07-08
97591817280878K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON2025-08-21
97591991303695K234012VITEK COMPACT PROLON2025-03-14
97591428133906K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON2024-03-11
3308671428133906K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON2024-03-11
97591231259373K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ2024-06-12
3308671231259373K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ2024-06-12
97591398877114K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)NGZ2024-06-07
3308671398877114K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)NGZ2024-06-07
97592065733366K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus PenicillinLON2023-10-23
3308672065733366K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus PenicillinLON2023-10-23
97591745152233K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP DaptomycinLON2023-07-05
3308671745152233K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP DaptomycinLON2023-07-05
97591047179699K230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN2024-06-20
97591627179255K223481VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)LON2023-02-03
3308671627179255K223481VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)LON2023-02-03
97591553255155K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN PlazomicinLON2023-02-16
3308671553255155K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN PlazomicinLON2023-02-16
97591381519264K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN FosfomycinLON2023-03-09
3308671381519264K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN FosfomycinLON2023-03-09
97591474667258K222378VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)LON2023-06-26
3308671474667258K222378VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)LON2023-06-26
97591407256092K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)LON2023-02-09
3308671407256092K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)LON2023-02-09
97591206437726K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenLON2022-10-13
3308671206437726K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenLON2022-10-13
97591605615652K220803VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP MoxifloxacinLON2023-01-27
3308671605615652K220803VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP MoxifloxacinLON2023-01-27
97591817842505K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)LON2022-04-14
3308671817842505K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)LON2022-04-14
97591159861971K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)LON2022-06-03
3308671159861971K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)LON2022-06-03
97591624805318K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS CaspofunginLON2022-07-12
3308671624805318K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS CaspofunginLON2022-07-12
97591402319659K213241VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS FluconazoleLON2022-02-25
3308671402319659K213241VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS FluconazoleLON2022-02-25
97592004365094K212849VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)LON2022-02-04
3308672004365094K212849VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)LON2022-02-04
97591595386780K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)LON2022-08-08
3308671595386780K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)LON2022-08-08
97591187639540K211630VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)LON2021-08-30
3308671187639540K211630VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)LON2021-08-30
97591455172546K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)LON2021-06-14
3308671455172546K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)LON2021-06-14
97591118608189K210287VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)LON2021-10-28
3308671118608189K210287VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)LON2021-10-28
97592016796042K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)LON2021-09-14
3308672016796042K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)LON2021-09-14
97591812779869K201675VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)LON2021-07-09
3308671812779869K201675VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)LON2021-07-09
97591132359229K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)LON2020-04-28
3308671132359229K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)LON2020-04-28
97591951517469K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)LON2020-03-13
3308671951517469K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)LON2020-03-13
97591453194829K193567VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)LON2020-02-14
3308671453194829K193567VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)LON2020-02-14
97591320590281K193299VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)LON2020-09-28
3308671320590281K193299VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)LON2020-09-28
97591379065502K192110Vitek DensichekLON2019-10-31
3308671379065502K192110Vitek DensichekLON2019-10-31
97591004959614K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)LON2019-08-05
3308671004959614K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)LON2019-08-05
97592026414414K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)LON2019-06-06
3308672026414414K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)LON2019-06-06
97562035384580K190405BACT/ALERT MP Reagent SystemMDB2019-05-15
3308672035384580K190405BACT/ALERT MP Reagent SystemMDB2019-05-15
97591708414493K183551VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)LON2019-03-07
3308671708414493K183551VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)LON2019-03-07
97592070488037K183524VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)LON2019-03-12
3308672070488037K183524VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)LON2019-03-12
97591669506464K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)LON2019-02-20
3308671669506464K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)LON2019-02-20
97591924967931K183360VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)LON2019-02-26
3308671924967931K183360VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)LON2019-02-26
97561664950732K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusMDB2019-02-11
3308671664950732K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusMDB2019-02-11
97591867165198K181766VITEK 2 AST-Gram Positive Inducible Clindamycin ResistanceLON2018-12-10
3308671867165198K181766VITEK 2 AST-Gram Positive Inducible Clindamycin ResistanceLON2018-12-10
97591378472382K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mLLON2017-12-19
3308671378472382K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mLLON2017-12-19
97591029844055K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)LON2017-12-08
3308671029844055K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)LON2017-12-08
97591310520682K163563VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)LON2017-03-13
3308671310520682K163563VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)LON2017-03-13
97591456632838K163083VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)LON2017-02-01
3308671456632838K163083VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)LON2017-02-01
97591883272043K163006VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)LON2017-01-24
3308671883272043K163006VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)LON2017-01-24
97591533019471K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)LON2017-06-21
3308671533019471K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)LON2017-06-21
97591615328219K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUOMDB2017-03-28
3308671615328219K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUOMDB2017-03-28
97591511965374K161510VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)LON2017-02-13
3308671511965374K161510VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)LON2017-02-13
97591455922687K161437VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)LON2017-02-16
3308671455922687K161437VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)LON2017-02-16
97591948106343K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)LON2016-07-20
3308671948106343K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)LON2016-07-20
97591068834959K161217VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)LON2017-01-12
3308671068834959K161217VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)LON2017-01-12
97591990287935K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)LON2016-04-15
3308671990287935K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)LON2016-04-15
97591146624721K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)NGZ2016-03-25
97591959467235K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLNGZ2016-02-18
97591027756254K141149VITEK 2 AST GP CEFTAROLINELON2014-06-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LON2162026-04-15
MDB272019-05-15
NGZ112024-06-12
LTW31978-03-02
SAN22026-07-08
LRH11996-08-30
GIM11994-02-07
LQL11991-07-26
JSP11991-04-03
JXB11988-06-16

PMA#

PMN#

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