Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013394941

FEI Number

3013394941

Entity Name

BIOMERIEUX SA

City/State/Country

Combourg Ille-et-Vilaine, FR

Establishment Address

4 bis, rue des Coutures, Combourg Ille-et-Vilaine 35270, 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

N/A

PMA Number

N/A

All Registered Proprietary Names

chromID VRE Agar CHROMID Candida Agar chromID P. aeruginosa agar NTM Elite agar chromID CARBA ChromID S. aureus Elite Agar chromID C. Difficile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2010-08-25
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	1992-08-25

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
K862389	Otisville Biotech, Inc.	BIOTIS ACETAMIDE AGAR	1986-07-03
K811644	Hardy Media	HEKTOEN ENTERIC AGAR	1981-07-02
K832535	Otisville Biotech, Inc.	HEKTOEN ENTERIC AGAR PLATE	1983-10-04
K811331	Acumedia Manufacturers, Inc.	SF BROTH	1981-05-29
K872058	Orion Corp.	ORICULT-N CULTURE-PADDLE	1987-06-10

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

Similar Registrations

Registration Number	Establishment Name	Location
8023060	BIO-RAD	STEENVOORDE Nord, FR
2022807	HARDY DIAGNOSTICS	Orcutt, CA, US
8010096	OXOID, LTD.	BASINGSTOKE, HAMPSHIRE, GB
1924669	REMEL, INC.	LENEXA, KS, US
3009547954	Hardy Diagnostics	Springboro, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013394941. Last updated year: 2026. Please use registration number 3013394941 when referencing this establishment in official correspondence.