FDA Registration Active 🇺🇸 United States

BIOMERIEUX, INC.

Reg #: 1950204 · FEI: 1950204 · Expires 2026
Products
19
Proprietary Names
356
Establishment Types
4
Classifications
19

Registration Details

Registration Name
BIOMERIEUX, INC.
Registration Number
1950204
FEI Number
1950204
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
595 ANGLUM RD.
City
HAZELWOOD
State
MO
ZIP
63042
Country
US

Regulatory Submissions

510(k) Number
K101566
PMA Number
N50510

Owner / Operator

Firm Name
BIOMERIEUX SA
Operator Number
8020790
Address
Chemin De L Orme
City
Marcy L Etoile
State
Rhone
Postal Code
69280
Country
FR

Products

Device Name Product Code
Susceptibility Test Plate, Antifungal NGZ
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems LRG
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation LON
Panels, Test, Susceptibility, Antimicrobial LTT
Susceptibility Test Cards, Antimicrobial LTW
Gram Positive Identification Panel LQL
Orthopedic Manual Surgical Instrument LXH
Monitor, Microbial Growth JTA
Calculator/Data Processing Module, For Clinical Use JQP
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples SAN
Gram Negative Identification Panel LQM
Stains, Microbiologic JTS
Kit, Identification, Yeast JXB
Kit, Anaerobic Identification JSP
System, Blood Culturing MDB
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates QBN
Instrument For Auto Reader Of Overnight Microorganism Identification System LRH
Kit, Fastidious Organisms JST

Proprietary Names

VITEK 2 YEAST CASPOFUNGIN DensiCHEK Plus VITEK 2 GP AST for Mupirocin VITEK 2 AST - Gram Negative Imipenem AST Streptococcus Vancomycin VITEK 2 AST - Gram Negative Ertapenem VITEK 2 GP AST for Amikacin VITEK 2 GP AST for Lincomycin VITEK 2 AST-Yeast Fluconazole VITEK 2 AST- Gram Negative Polymyxin B VITEK 2 GN AST for Cefperazone VITEK 2 AST-GP Tobramycin VITEK 2 AST-GP Telithromycin VITEK 2 AST-GP Pefloxacin VITEK 2 AST-GP Kanamycin High Level (synergy) VITEK 2 AST-GP Gentamicin High-Level Resistance VITEK 2 AST-GP Flomoxef VITEK 2 AST-GP Gatifloxacin VITEK 2 AST-GP Cefuroxime VITEK 2 AST-GP Cefpodoxime VITEK 2 AST-GP Fusidic Acid VITEK 2 AST-GP Trimethoprim VITEK 2 AST-GP Cefalotin VITEK 2 AST-GP Trimethoprim/ Sulfamethoxazole VITEK 2 AST-GP Imipenem VITEK 2 AST-GP Amoxicillin/ Clavulanic Acid VITEK 2 AST-GP Mupirocin VITEK 2 AST-GP Teicoplanin VITEK 2 AST-GP Kanamycin VITEK 2 AST-GP Lincomycin VITEK 2 AST-GP Quinupristin/ Dalfopristin VITEK 2 AST-GP Habekacin VITEK 2 AST-GP Netilmicin VITEK 2 AST-GP Cefmetazole VITEK 2 AST-GP Erythromycin VITEK 2 AST-GP Rifampicin VITEK 2 AST-GP Fosfomycin VITEK 2 AST-GP Amoxicillin VITEK 2 AST-GP Amikacin VITEK 2 AST-GP Pristinamycin VITEK 2 AST-GP Cefotaxime VITEK 2 AST-GP Ertapenem VITEK 2 AST-GP Clarithromycin VITEK 2 AST-ST Gentamicin VITEK 2 AST-ST Teicoplanin VITEK 2 AST-ST Chloramphenicol VITEK 2 AST-ST Rifampicin VITEK 2 Streptococcus Tetracycline VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE VITEK 2 AST-Yeast Caspofungin VITEK 2 GN AST for Cefpirome VITEK 2 GP for Quinupristin / Dalfopristin VITEK 2 AST-Gram Negative Cefazolin VITEK 2 AST-GN Ceftolozane/Tazobactam VITEK 2 Gram Negative Piperacillin AST Penicillin VITEK 2 GN AST for Cefixime VITEK 2 GN AST for Tosufloxacin VITEK REVEAL GN01-AST VITEK 2 GN AST for Cefepime Rapid Coryne System for Ident. of Coryneform Bacteria VITEK 2 Gram Positive Identification (GP) VITEK 2 GN AST for Cefalexine VITEK 2 AST-ST Meropenem VITEK 2 GP AST for Habekacin VITEK 2 GN AST for Polymyxin B ML) VITEK(R) 2 YEAST FLUCONAZOLE (1-64U VITEK 2 AST-Gram Negative Ceftazidime VITEK 2 GN AST for Mezlocillin VITEK 2 GP Cefoxitin Screen VITEK 2 GN AST for Fosfomycin Cefperazone/Sulbactam VITEK 2 GN AST for VITEK 2 Streptococcus Penicillin VITEK 2 Gram Negative for Pipercillin/Tazobactam VITEK 2 AST-Gram Negative Imipenem/Relebactam VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance VITEK 2 Streptococcus Trimethoprim/Sulfamethoxazole Imipenem VITEK 2 GP S. pneumo AST for VITEK 2 GN AST for Cefcapene HOOK STAGING TRAY (CA-SFM) VITEK 2 GN AST for Nitrofurantoin VITEK 2 AST-GN Ciprofloxacin VITEK 2 Gram Negative Levofloxacin VITEK 2 AST-Yeast Voriconazole VITEK 2 GN AST for Cefaclor VITEK 2 GN AST for Cefozopran VITEK 2 GRAM POSITIVE DOXCYCLINE , 3D MB ACT BACT/ALERT-120 MB BACT MYCOBACTERIA DETECTION SYSTEM BACT/ALERT 120/140 BACT/ALERT VITEK 2 AST-Gram Negative Tobramycin VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance VITEK 2 GP AST for Nitrofurantoin NSV2 instal DVD eM W7 easySTREAM NSV2 RP5800 Master ARGENE connect Goldmaster RP5810 V1 NucliSENTRAL OBSERVA VITEK REVEAL Sealer VITEK REVEAL Sensor Panel VITEK REVEAL BC GN02-AST VITEK REVEAL VITEK 2 GP AST for Fosfomycin VITEK 2 AST-Gram Positive Fosfomycin VITEK 2 Gram Positive Daptomycin VITEK 2 GP Amoxicillin for S pneumo VITEK 2 Gram Negative Doripenem VITEK 2 GN AST for Cefditoren VITEK 2 AST-ST Clindamycin VITEK 2 GN AST for Cefotiam VITEK 2 Gram Positive Tigecycline Gatifloxacin (<= 0.12 - >= 8 mcg/ml) Trimethoprim / Sulfamethoxazole VITEK 2 Gram Positive VITEK 2 AST-ST Moxifloxacin VITEK 2 Compact VITEK 2 AST-GN Tigecycline VITEK 2 Gram Negative Meropenem VITEK® 2 Gram-Negative identification card (GN) VITEK 2 Gram Positive Linezolid VITEK 2 GN Doxycycline VITEK 2 Gram Negative Moxifloxacin VITEK 2 Yeast AST - Amphotericin B VITEK® 2 AST-GN Gentamicin VITEK 2 AST-GN Ceftazidime/Avibactam VITEK 2 GP AST for Netilmicin VITEK 2 GN AST for Cefteram VITEK 2 AST-GN Piperacillin/tazobactam VITEK 2 AST-Yeast Anidulafungin VITEK 2 GP Linezolid for S. pneumo VITEK 2 GN AST for Ofloxacin Vitek 2 AST-Yeast Micafungin FUCHSIN-A (NA) CRYSTAL VIOLET-C (NA) ACETONE SAFRANIN-A (NA) IODINE-B (NA) ACETONE FUCHSIN-A SAFRANIN-A (NA) VITEK 2 GP Meropenem for S. pneumo VITEK® 2 Yeast identification card (YST) VITEK 2 GP AST for Imipenem VITEK 2 GP Telithromycin for VITEK 2 AST-ST Inducible Clindamycin Resistance VITEK® 2 Anaerobic and Corynebacteria identification card (ANC) VITEK 2 GP Levofloxacin for VITEK 2 AST-ST Ampicillin VITEK 2 AST-Gram Negative Omadacycline VITEK 2 GP Moxifloxacin for VITEK 2 Gram Negative Ceftriaxone VITEK 2 Gram Positive Ertapenem VITEK®2 AST-YS Flucytosine VITEK 2 GN AST for Faropenem VITEK 2 GP AST for Cefmetazole VITEK 2 AST-Gram Positive Lefamulin VITEK 2 Gram Negative Gatifloxacin BacT/ALERT 3D with Mycobacterium Indication VITEK 2 AST-Streptococcus Cefuroxime VITEK 2 AST-Gram Positive Dalbavancin VITEK 2 AST-Gram Negative Fosfomycin VITEK 2 Yeast AST for Flucytosine VITEK 2 Gram Negative Tigecycline VITEK2 AST-Gram Negative Delafloxacin VITEK 2 AST-YS Amphotericin B VITEK 2 AST-YS Caspofungin VITEK 2 AST-YS Flucytosine VITEK 2 AST-YS Micafungin VITEK 2 AST-Gram Positive Cefoxitin Screen VITEK 2 AST-Gram Negative Meropenem VITEK 2 GP AST for Cefotaxime AST-GN Imipenem VITEK 2 AST- Gram Positive Telavancin VITEK 2 GP AST for Ertapenem VITEK 2 GN AST for Minocycline VITEK 2 AST-Gram Negative Piperacillin / Tazobactam VITEK 2 Gram Positive Meropenem Vitek 2 AST Gram Negative Cefazolin VITEK 2 AST-GP Ceftaroline VITEK 2 AST-Gram Negative Minocycline PreviISOLA VIDAS 3 ASSAY DILUTION CUP VIDAS 3 SAMPLE TIP Dry Blood Spot Puncher VITEK 2 AST-Gram Negative Levofloxacin AST Clindamycin VITEK 2 GP AST for Cefaclor VITEK 2 GP AST for Fusidic Acid VITEK 2 AST- Streptococcus Cefotaxime VITEK 2 AST-Gram Negative Plazomicin VITEK 2 AST-Streptococcus Penicillin VITEK 2 AST-Gram Negative Ciprofloxacin VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) VITEK 2 AST-Gram Negative Meropenem/Vaborbactam VITEK 2 GP AST for Kanamycin VITEK 2 AST-ST Erythromycin VITEK 2 AST-ST Linezolid VITEK 2 AST-GN Tosufloxacin VITEK 2 AST-GN Piperacillin/ Sulbactam VITEK 2 AST-GN Chloramphenicol VITEK 2 AST-GN Cefmetazole VITEK 2 AST-GN Minocycline VITEK 2 AST-GN Panipenem VITEK 2 AST-GN Cefozopran VITEK 2 AST-GN Ertapenem VITEK 2 AST-GN Latamoxef VITEK 2 AST-GN Cefalexin VITEK 2 AST-GN Cefditoren VITEK 2 AST-GN Piperacillin/ Tazobactam VITEK 2 AST-GN Cefaclor VITEK 2 AST-GN Mecillinam VITEK 2 AST-GN Cefoperazone VITEK 2 AST-GN Ampicillin/Sulbactam VITEK 2 AST-GN Trimethoprim VITEK 2 AST-GN Cefotaxime VITEK 2 AST-GN Cefoperazone/ Sulbactam VITEK 2 AST-GN Cefepime VITEK 2 AST-GN Fosfomycin VITEK 2 AST-GN Polymyxin B VITEK 2 AST-GN Ceftriaxone VITEK 2 AST-GN Cefotiam VITEK 2 AST-GN Amoxicillin/Clavulanic Acid VITEK 2 AST-GN Ceftazidime VITEK 2 AST-GN Flomoxef VITEK 2 AST-GN Ofloxacin VITEK 2 AST-GN Colistin VITEK 2 AST-GN Cefpirome VITEK 2 AST-GN Netilmicin VITEK 2 AST-GN Cefcapene VITEK 2 AST-GN Pefloxacin VITEK 2 AST-GN Faropenem VITEK 2 AST-GN Cefteram VITEK 2 AST-GN Rifampicin VITEK 2 AST-GN Temocillin VITEK 2 AST-GN Isepamicin VITEK 2 AST-GN Cefixime VITEK 2 AST - Gram Negative Colistin VITEK 2 Gram Positive Inducible Clindamycin Resistance AST Cefotaxime VITEK® 2 AST-YS Caspofungin VITEK 2 GP AST for Kanamycin HL VITEK 2 AST-ST Levofloxacin VITEK 2 GN AST for Chloramphenicol VITEK 2 Gram Positive VRSA Screen VITEK MS Prime Vitek Compact Pro VITEK 2 GP Erythromycin for VITEK 2 GP Ertapenem for S. pneumo VITEK 2 AST-GN Levofloxacin VITEK 2 AST-GP Penicillin G VITEK 2 AST-GP Streptomycin, HL VITEK 2 AST-GP Clindamycin VITEK 2 AST-GN Imipenem VITEK 2 AST-GN Tobramycin VITEK 2 AST-GP Ciprofloxacin VITEK 2 AST-GN Cefazolin VITEK 2 AST-GP Gentamicin, HL VITEK 2 AST-GN Cefpodoxime VITEK 2 AST-GP for S.pn Penicillin G VITEK 2 AST-GN Tetracycline VITEK 2 AST-GP for S.pn Ofloxacin VITEK 2 AST-GN Cefalotin VITEK 2 AST-GP Levofloxacin VITEK 2 AST-GN Cefuroxime VITEK 2 AST-GP Rifampin VITEK 2 AST-GN Meropenem VITEK 2 AST-GP Sparfloxacin VITEK 2 AST-GN Gentamicin VITEK 2 AST-GN Ampicillin VITEK 2 AST-GP Gentamicin VITEK 2 AST-GP for S.pn Tetracycline VITEK 2 Antimicrobial Susceptibility Test Device (GN, GP, and GP for S.pn) VITEK 2 AST-GN Ticarcillin/ Clavulanic Acid VITEK 2 AST-GP for S.pn Chloramphenicol VITEK 2 AST-GP Amp/Sulbactam VITEK 2 AST-GN Nitrofurantoin VITEK 2 AST-GN Amox/Clav VITEK 2 AST-GN Nalidixic Acid VITEK 2 AST-GP for S.pn Cefotaxime VITEK 2 AST-GN Amp/Sulbactam VITEK 2 AST-GN Piperacillin VITEK 2 AST-GP Cefazolin VITEK 2 AST-GN Ticarcillin VITEK 2 AST-GN Cefoxitin VITEK 2 AST-GP for S.pn Trimeth./sulfa VITEK 2 AST-GN Pip/Tazob. VITEK 2 AST-GP Chloramphenicol VITEK 2 AST-GN Amikacin VITEK 2 AST-GN Norfloxacin VITEK 2 AST-GP Norfloxacin VITEK 2 AST-GN Trimeth./sulfa VITEK 2 AST-GP Nitrofurantoin VITEK 2 AST-GP Ofloxacin VITEK 2 AST-GP for S.pn Vancomycin VITEK 2 AST-GP Minocycline VITEK 2 AST-GN Aztreonam VITEK 2 AST-GN Cefotetan VITEK 2 AST-GP for S.pn Ceftriaxone VITEK 2 AST-GN Ceftizoxime VITEK 2 AST-GP Vancomycin VITEK 2 AST-GP Tetracycline VITEK 2 AST-GP Ampicillin VITEK 2 AST-GP Oxacillin BacT/ALERT VIRTUO Microbial Detection System VITEK 2 Gram Positive Vancomycin VITEK 2 AST-Gram Negative Eravacycline VITEK 2 Gram Negative Ertapenem VITEK 2 GN AST for Netilmicin VITEK 2 AST Streptococcus Ceftriaxone VITEK 2 AST-Gram Positive Moxifloxacin Pipercillin/Sulbactam VITEK 2 AST-ST Tigecycline VITEK 2 GN AST for Cefsulodin VITEK 2 GP AST for Minocycline Trimethoprim/Sulfamethoxazole VITEK 2 YEAST VORICONAZOLE VITEK 2 AST-Gram Positive Delafloxacin VITEK 2 GP AST for Oxacillin Screen VITEK 2 GP AST for Cefuroxime Amoxicillin VITEK 2 GP for S. pneumo AST for VITEK 2 Gram Positive Erythromycin VITEK 2 AST-Gram Positive Daptomycin VITEK 2 ESBL Test VITEK 2 GN AST for Isepamicin VITEK 2 GN AST for Colistin VITEK®2 AST-YS Fluconazole and BacT/ALERT 3D60 Instrument 3D Combination BacT/ALERT Blood Culturing System (240), VITEK 2 AST-Gram Positive Linezolid Ofloxacin VITEK DENSICHEK VITEK 2 AST Gram Negative Cefotaxime VITEK Gram Negative Identification Plus Card (GNI+) VITEK 2 Gram Positive Moxifloxacin Ampicillin/Sulbactam VITEK 2 GP Sparfloxacin for S.pn VITEK 2 GN AST for Mecillinam VITEK 2 GN AST for Flomoxef VITEK 2 Gram Positive Gatifloxacin VITEK® 2 Neisseria-Haemophilus identification card (NH)

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)