Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009307598

FEI Number

3009307598

Entity Name

BIOMERIEUX SPAIN

City/State/Country

Tres Cantos Madrid (Province), ES

Establishment Address

Isaac Newton, 6, Tres Cantos Madrid (Province) 28760, ES

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

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 Slidex Staph Plus ID 32 Staph API STAPH chromID MRSA / chromID S. aureus chromID MRSA chromID MRSA 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
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	1999-07-20
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2004-08-24
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2016-03-22
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2016-10-25
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
9615778	BioMerieux SA	VERNIOLLE Ariege, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17
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

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 3009307598. Last updated year: 2026. Please use registration number 3009307598 when referencing this establishment in official correspondence.