BIOMERIEUX SA

FDA Device Registration & Listing · LA BALME LES GROTTES Isere, FR · Registration 9615754

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615754
FEI Number
3008237827
Entity Name
BIOMERIEUX SA
City/State/Country
LA BALME LES GROTTES Isere, FR
Establishment Address
3 ROUTE DE PORT MICHAUD, LA BALME LES GROTTES Isere 38390, FR
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
N
Expiration Date (Year)
2026
510(k) Number
K250856
PMA Number
N/A

All Registered Proprietary Names

ETEST Gepotidacin (GEP) VITEK® MS ETEST Trimeth./Sulphamethoxazole ETEST OFLOXACIN Rapid Coryne System for Ident. of Coryneform Bacteria VITEK 2 Gram Positive Identification (GP) ETEST MOXIFLOXACIN API M MEDIUM ETEST Meropenem/Vaborbactam ETEST Antifungal Susc. Testing Streptococcus spp. and Anaerobic Gram Negative Aerobic Bacteria, Bacteria ETEST FOSFOMYCIN ETEST AMOX./CLAV. ACID 2/1 ETEST SUBMISSION FOR IMIPENEM NSV2 instal DVD eM W7 easySTREAM NSV2 RP5800 Master ARGENE connect Goldmaster RP5810 V1 NucliSENTRAL OBSERVA ETEST CEFTRIAXONE Etest Ceftolozane/ Tazobactam (016-256 ?g/ml) ETEST TOBRAMYCIN 016-256 UG/ML AND 064-1024 UG/ML Etest Ceftaroline (002 - 32ug/ml) VITEK MS ETEST TETRACYCLINE ETEST TICARCILLIN/CLAVULANIC ACID 2 ETEST PIPERACILIN TAZOBACTAM 4 UG Etest Ceftazidime/Avibactam (CZA) (016 - 256 ?g/ml) VIDAS 3 MiniVIDAS Instrument ETEST Fosfomycin ETEST AMPICILLIN/SULBACTAM 2/1 ETEST Piperacillin/Tazobactam (P/T) Rapid 20 E API 20 NE API 20 E (100) API 20 E (25) ID Indole TDA Rapid ID 32 E ETEST VANCOMYCIN API 50 CHB MEDIUM API 50 CH API 50 CHL MEDIUM Multi. General Nutrient Broth ETEST CEFTAROLINE ETEST CEFTAZIDIME ETEST CIPROFLOXACIN ETEST Eravacycline (ERV) ETEST ERTAPENEM ETEST AZITHROMYCIN ETEST Voriconazole ETEST Doripenem - MIC at 002-32 ug/ml ETEST GEMIFLOXACIN VIDAS system VITEK Immunodiagnostic Assay System APIWeb MYLA ETEST Plazomicin (PLZ) ETEST Imipenem/Relebactam P. aeruginosa (IRPA) ETEST CEFTRIAXONE for HAEMOPHILUS & PNEUMOCOCCUS ETEST DAPTOMYCIN ETEST AZITHROMYCIN ETEST LEVOFLOXACIN ETEST CEFTRIAXONE ETEST QUINUPRISTIN/DALFOPRISTIN ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE ETEST CEFEPIME ETEST Telavancin (TLA) (002-32 ?g/mL) ETEST LINEZOLID ETEST Delafloxacin (DFX) ETEST Imipenem/Relebactam (IPR) API CORYNE REACTIFS VP1 VP2 4AMP API Reagents (Multiple) ZYM B X2 NIN X2 API RAPIDEC Staph VP1 VP2 Reagents API Strep, Coryne, Zym and NH VPA VPB Reagents Rapid ID32 Strep API LISTERIA API CAMPY API SUSP API ZYM HUILE DE PARAFFINE API RAPID ID 32 STREP REACTIFS NIT 1+NIT 2 4AMP PYZ 2 AMP API NACL 0.85% MCFARLAND STANDARD BCP POURPRE DE BROMOCRESOL1AMP EHR (EHRLICH) 1 AMP API 20 STREP REACTIFS VPA VPB 2AMP API NH NIN 2 AMP XYL (XYLENE) REACTIF TDA 2AMP API Mineral Oil ID COLOR CATALASE JAMES 2 AMP ZN (POUDRE DE ZINC) FB (FAST BLUE BB) 2 AMP ETEST ESBL TZ/TZL STRIP ETEST ESBL CT/CTL STRIP; Slidex Staph Plus ID 32 Staph API STAPH VITEK® MS ETEST Aztreonam/Avibactam

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2026-05-05
PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Microbiology Class 2 866.3361 2017-08-07
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
LQL Gram Positive Identification Panel Microbiology Class 1 866.2660 2007-12-31
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-09
JSH Culture Media, Non-Selective And Differential Microbiology Class 1 866.2320 1999-08-17
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2019-02-14
NGZ Susceptibility Test Plate, Antifungal Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-03-22
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2007-08-29
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2017-02-06
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2017-06-02
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2011-01-16
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-11-18
PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Microbiology Class 2 866.3361 2013-09-10
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2017-09-15
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2007-12-27
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2022-03-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2019-05-14
JSS Kit, Identification, Enterobacteriaceae Microbiology Class 1 866.2660 1999-08-17
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-09
JSC Culture Media, General Nutrient Broth Microbiology Class 1 866.2350 1999-08-17
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2013-01-30
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2019-10-21
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2018-08-02
NGZ Susceptibility Test Plate, Antifungal Microbiology Class 2 866.1640 2009-12-23
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
DEW Igg, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-12-27
OUG Medical Device Data System General Hospital Class 1 880.6310 2014-11-17
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2020-05-14
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2025-05-20
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-03-22
LTX Discs, Elution Microbiology Class 2 866.1620 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2018-07-06
LTX Discs, Elution Microbiology Class 2 866.1620 2009-02-11
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2019-12-02
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2019-10-21
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 1999-07-20
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2009-02-11
JWX Kit, Screening, Staphylococcus Aureus Microbiology Class 1 866.2660 2004-08-24
QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Microbiology Class 2 866.3378 2018-12-31
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2025-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

Nathan Hardesty Business: BioMerieux, SA Email: nathan.hardesty@biomerieux.com Phone: (314) 7318666

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
K944753 Radiometer America, Inc. SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP 1995-02-24
K232967 bioMerieux, Inc. VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) 2024-06-12
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14
K872302 Ciba Corning Diagnostics Corp. MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER 1987-09-08
K760790 General Diagnostics MICRO-ID 1976-10-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-04 Misys Healthcare Systems 1
Calculator/Data Processing Module for Clinical Use
Z-0026-2025 Becton Dickinson & Co. 1
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Z-0008-06 Abbott Laboratories, Inc 1
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024 Ortho-Clinical Diagnostics, Inc. 1
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06 Beckman Coulter Inc 1
Synchron LX Systems Version 4.5 Operating Software

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615754. Last updated year: 2026. Please use registration number 9615754 when referencing this establishment in official correspondence.
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