Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615755

FEI Number

3007808629

Entity Name

BIOMERIEUX FRANCE

City/State/Country

CRAPONNE Rhone, FR

Establishment Address

5 RUE DE ACQUEDUCS, CRAPONNE Rhone 69290, 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

Expiration Date (Year)

2026

510(k) Number

K181092

PMA Number

N/A

All Registered Proprietary Names

Slidex Staph Plus ID 32 Staph API STAPH TRYPCASE SOYA BROTH 20TUBES OEM Microscan Broth ID 32 C Qualitest - Albicans API 20 C AUX ALBICANS ID2 Rapid 20 E API 20 NE API 20 E (100) API 20 E (25) ID Indole TDA Rapid ID 32 E kit RAL Stainer Fluo RAL kit RAL Stainer Cold ZN PREVI FLUO TB chromID VRE Agar Todd Hewitt + Antibiotics (TODD H-T) ChromID® Strepto B Agar CHROMID Candida Agar chromID P. aeruginosa agar NTM Elite agar chromID CARBA ChromID S. aureus Elite Agar chromID C. Difficile 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 CHROMID CARBA agar (CARB)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2004-08-24
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2000-08-30
JXB	Kit, Identification, Yeast	Microbiology	Class 1	866.2660	1999-08-17
JSS	Kit, Identification, Enterobacteriaceae	Microbiology	Class 1	866.2660	1999-08-17
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2012-03-16
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2010-08-25
JSD	Culture Media, Selective Broth	Microbiology	Class 1	866.2360	1992-08-25
PQZ	Gbs Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2017-01-27
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	1992-08-25
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	1999-07-20
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2018-07-06

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
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30
K080719	Advandx, Inc.	YEAST TRAFFIC LIGHT PNA FISH	2008-09-12
K760790	General Diagnostics	MICRO-ID	1976-10-29
K862389	Otisville Biotech, Inc.	BIOTIS ACETAMIDE AGAR	1986-07-03
K811644	Hardy Media	HEKTOEN ENTERIC AGAR	1981-07-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2008	Pml Microbiologicals Inc.	2	Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
Z-0014-2008	Pml Microbiologicals Inc.	2	Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615755. Last updated year: 2026. Please use registration number 9615755 when referencing this establishment in official correspondence.