Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008249922

FEI Number

3008249922

Entity Name

BIOMERIEUX SA - Grenoble

City/State/Country

Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR

Establishment Address

5 Rue des Berges, Grenoble Cedex 01 Auvergne-Rhone-Alpes 38024, 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

EASY Q READER NUCLISENS EASY Q INCUBATOR NUCLISENS READER NucliSens EasyMag Reagents Stool Preprocessing Device NUCL.MAGN.SILICA(24X1,2ML)384T MAGNETIC EXTRACTION RE NUCL. LYSIS BUF. (4X1L) 384T NucliSens kit auto.Extrac.50t. NucliSens Lysis buffer 9ml 50t NucliSens Cart.Extracteur x50. NucliSens Sol.Rincage 4x1l NUCL. MAGNETIC ISOLATION REAG NUCL. EXTR. BUFFER 2(4X1L)384T NucliSens Tampon dosage 4x1l NucliSens Magnetic Extraction Rgnt. NUCLIS.BASIC KIT DET.ECL NUCL. LYSIS BUF 2ML 48T NUCL. EXTR. BUFFER 3(4X1L)384T QC - WET TEST EASY-Q NUCL. EXTR. BUFFER 1(4X1L)384T BASIC KIT BEADS BUFFER 4PCK NUCLIS.LYSIS BUF 500ML NUCLIS. EXTR. ETHANOL 4/PACK NUCLIS. EXTR. ACETON 4/PACK MICROTUBES 1,5 ML NUCLIS.BASIC KIT AMP NucliSens Lysis buff,9ml 50t KIT EXTRACTION NUCLISENS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2003-11-04
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2004-07-07

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
3009307598	BIOMERIEUX SPAIN	Tres Cantos Madrid (Province), ES
9615778	BioMerieux SA	VERNIOLLE Ariege, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008249922. Last updated year: 2026. Please use registration number 3008249922 when referencing this establishment in official correspondence.