Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1950204

FEI Number

1950204

Entity Name

BIOMERIEUX, INC.

City/State/Country

HAZELWOOD, MO, US

Establishment Address

595 ANGLUM RD., HAZELWOOD, MO 63042, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOMERIEUX SA (Owner Number: 8020790)

Owner / Operator Contact Address

Chemin De L Orme, Marcy L Etoile, FR-69 69280, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051849

PMA Number

N/A

All Registered 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 Streptococcus Tetracycline 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 (CA-SFM) 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 DensiCHEK Plus VITEK 2 AST-ST Clindamycin VITEK 2 GN AST for Cefotiam VITEK 2 Gram Positive Tigecycline VITEK 2 GP S. pneumo AST for Gatifloxacin (<= 0.12 - >= 8 mcg/ml) VITEK 2 Gram Positive Daptomycin 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 S. pneumo VITEK 2 AST-ST Inducible Clindamycin Resistance VITEK® 2 Anaerobic and Corynebacteria identification card (ANC) S. pneumo VITEK 2 GP Levofloxacin for VITEK 2 AST-ST Ampicillin VITEK 2 AST-Gram Negative Omadacycline S. pneumo VITEK 2 GP Moxifloxacin for VITEK 2 AST-Gram Negative Imipenem/Relebactam 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 S. pneumo VITEK 2 GP Erythromycin for VITEK 2 GP Ertapenem for S. pneumo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2011-01-16
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2011-01-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2010-02-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-02-21
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-21
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-21
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2016-05-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2016-05-09
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2016-05-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-02-28
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2020-02-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2020-02-17
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2020-02-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-03-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-01-03
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2022-07-13
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2022-07-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-07-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2025-08-26
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2017-02-14
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2017-02-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-02-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-01-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LQL	Gram Positive Identification Panel	Microbiology	Class 1	866.2660	2007-12-31
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-12-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2006-11-20
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2020-10-15
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2020-10-15
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2020-10-15
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-02-07
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-11-03
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-03-06
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2021-06-22
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-06-22
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2021-06-22
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-02-06
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-03-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-09-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-06-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2024-06-18
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2024-06-18
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2024-06-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-06-18
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2024-06-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-01-16
JTA	Monitor, Microbial Growth	Microbiology	Class 1	866.2560	2003-11-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2017-02-20
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2017-02-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-02-20
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2026-05-12
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2026-05-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2026-05-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2007-08-29
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-07-31
SAN	Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples	Microbiology	Class 2	866.1650	2024-07-31
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-09-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2010-02-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2009-12-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-10-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2009-06-24
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-09-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-27
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2017-01-25
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2017-01-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-01-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2010-02-18
LQM	Gram Negative Identification Panel	Microbiology	Class 1	866.2660	2014-11-19
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-01
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-01
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-02-01
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-12-22
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2017-12-22
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2017-12-22
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2024-06-10
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2024-06-10
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2024-06-10
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2024-06-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-06-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2016-05-09
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2016-05-09
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2016-05-09
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2016-05-09
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2009-05-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
JXB	Kit, Identification, Yeast	Microbiology	Class 1	866.2660	2007-12-31
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-11-04
JSP	Kit, Anaerobic Identification	Microbiology	Class 1	866.2660	2007-12-31
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-10-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-06-08
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2020-03-17
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2020-03-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2020-03-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-01-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2014-12-19
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2024-03-26
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2024-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-19
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2026-05-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2026-05-12
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2026-05-12
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-06-17
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-03-13
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-03-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-03-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-03-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-03-13
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-03-13
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2015-09-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-10-18
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2022-10-18
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2022-10-18
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2021-07-20
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2021-07-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-07-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-10-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-08-10
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2022-08-10
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2022-08-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-09-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-02-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2014-06-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-03-08
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-03-08
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-03-08
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-01-16
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-10-28
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-03-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-03-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-03-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-10-24
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-10-24
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-10-24
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-06-21
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-01-06
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-02-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-03-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-08-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2015-11-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2016-02-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-10-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3378	2022-03-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2025-03-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOMERIEUX SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1450405	BIOMERIEUX, INC.	LOMBARD, IL, US
3023036790	Specific Diagnostics	San Jose, CA, US
3025775667	BIOMERIEUX, INC.	Salt Lake City, UT, US
3008249922	BIOMERIEUX SA - Grenoble	Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR
3009307598	BIOMERIEUX SPAIN	Tres Cantos Madrid (Province), ES

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K232967	bioMerieux, Inc.	VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)	2024-06-12
K033458	Becton, Dickinson & CO	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST	2004-05-28
K112000	bioMerieux, Inc.	VITEK 2 STREPTOCOCCUS PENICILLIN	2011-10-26
K010508	Pasco Laboratories, Inc.	PASCO MIC AND MIC/ID PANELS	2001-04-23
K111394	Siemens Healthcare Diagnostics, Inc.	MICROSCAN MICROSTEP	2011-06-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0170-2015	Siemens Healthcare Diagnostics, Inc.	2	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

Similar Registrations

Registration Number	Establishment Name	Location
1530126	Remel Cleveland, A Division of Remel Inc.	Oakwood Village, OH, US
9615754	BIOMERIEUX SA	LA BALME LES GROTTES Isere, FR
8021914	TREK DIAGNOSTIC SYSTEMS, LTD.	East Grinstead West Sussex, GB
3013718871	UPS Supply Chain Solutions, Inc.	Pedricktown, NJ, US
3031977134	bioMerieux, Inc.	Morrisville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1950204. Last updated year: 2026. Please use registration number 1950204 when referencing this establishment in official correspondence.