FDA.reportPublic FDA data

BIOMERIEUX

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
80207901000611339BIOMERIEUX SA1N2026-01-01CHEMIN DE L ORME MARCY L ETOILE Rhone FR 69280
96157781000351505BioMerieux SA1N2026-01-01PARC TECHNOLOGIQUE DELTA SUD VERNIOLLE Ariege FR 09340
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
97641537244710K993319VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210LGD2000-05-22
1483741525569376K982311BARTELS CINAKIT CMV ANTIGENEMIAGQH1998-12-14
97591719697936K981736BACT/ALERT 3D MICROBIAL DETECTION SYSTEMMDB1998-07-24
3308671719697936K981736BACT/ALERT 3D MICROBIAL DETECTION SYSTEMMDB1998-07-24
97641770102084K965084VIDAS PROESTERONE (PRG) (30 409)JLS1997-01-09
97591368307575K962609GRAM NEGATIVE IDENTIFICATION PLUS CARDLRH1996-08-30
97641745557297K955647VIDAS ESTRADIOL II (E2II) ASSAYCHP1996-02-06
97641379022031K943811ENZYME-LINKED FLUORESCENT IMMUNOASSAYCFT1994-11-02
97561067684892K933939BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERTGIM1994-02-07
97641450844303K933549VIDAS CMV IGM ASSAYLKQ1994-08-02
97641611155107K931031VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENTJFT1993-07-27
97641423114172K926393VIDAS THYROXINE (T4) ASSAY (T4)KLI1993-05-13
97641269410502K923903VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSALJY1993-08-09
97641002959347K923166VIDAS TOXOPLASMA GONDII IGM ASSSAYLGD1993-02-25
97641281385715K923122VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMLFY1992-10-26
97641825876568K921816VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAYJLW1992-06-18
97641231628086K921746VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMCGJ1992-06-16
97641905594449K921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMJHI1992-07-28
97641499689746K921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMCEP1992-04-08
97641411609845K920661VIDAS CMV IGG ASSAYLFZ1993-02-12
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
97591593912752K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON2026-04-15
97591673548259K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON2026-03-26
97591817280878K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON2025-08-21
97641799160986K240279VIDAS TBI (GFAP, UCH-L1)QAT2024-05-01
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
97641533054064K210793VIDAS NEPHROCHECKPIG2022-07-08
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
97642034395095K162827VIDAS B.R.A.H.M.S. PCT (PCT)PRI2017-02-23

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
LGD32011-05-18
LTW31978-03-02
LSR22013-06-04
SAN12024-06-20
QAT12024-05-01
PIG12022-07-08
PRI12017-02-23
PMT12016-06-28
MCB12013-10-09
DAP12012-07-31
LFX12008-12-23
LLH12008-06-11
NTM12007-10-11
LYR12000-10-04
GQH11998-12-14
JLS11997-01-09
LRH11996-08-30
CHP11996-02-06
CFT11994-11-02
LKQ11994-08-02
GIM11994-02-07
LJY11993-08-09
JFT11993-07-27
KLI11993-05-13
LFZ11993-02-12
LFY11992-10-26
JHI11992-07-28
JLW11992-06-18
CGJ11992-06-16
CEP11992-04-08
LQL11991-07-26
JSP11991-04-03
JXB11988-06-16

PMA#

156 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

GUDID#

NEPHROCHECK Test Kit - The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older.

BIOMERIEUX SA

2016-08-12

80 records. Showing 1-40. Next