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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Susceptibility Test Plate, Antifungal | NGZ | Class 2 | Microbiology | No | 2011-01-16 |
| Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | LRG | Class 2 | Microbiology | No | 2011-01-16 |
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | Class 2 | Microbiology | No | 2010-02-18 |
| Panels, Test, Susceptibility, Antimicrobial | LTT | Class 2 | Microbiology | No | 2019-02-21 |
| Susceptibility Test Cards, Antimicrobial | LTW | Class 2 | Microbiology | No | 2019-02-21 |
| Gram Positive Identification Panel | LQL | Class 1 | Microbiology | No | 2007-12-31 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-09-20 |
| Monitor, Microbial Growth | JTA | Class 1 | Microbiology | No | 2003-11-04 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2007-08-29 |
| Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | SAN | Class 2 | Microbiology | No | 2024-07-31 |
| Gram Negative Identification Panel | LQM | Class 1 | Microbiology | No | 2014-11-19 |
| Stains, Microbiologic | JTS | Class 1 | Hematology | No | 2009-05-27 |
| Kit, Identification, Yeast | JXB | Class 1 | Microbiology | No | 2007-12-31 |
| Kit, Anaerobic Identification | JSP | Class 1 | Microbiology | No | 2007-12-31 |
| System, Blood Culturing | MDB | Class 1 | Microbiology | No | 2007-12-19 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2011-01-16 |
| Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | QBN | Class 2 | Microbiology | No | 2022-03-16 |
| Instrument For Auto Reader Of Overnight Microorganism Identification System | LRH | Class 1 | Microbiology | No | 2007-12-31 |
| Kit, Fastidious Organisms | JST | Class 1 | Microbiology | No | 2014-11-19 |
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)