Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615778

FEI Number

1000351505

Entity Name

BioMerieux SA

City/State/Country

VERNIOLLE Ariege, FR

Establishment Address

PARC TECHNOLOGIQUE DELTA SUD, VERNIOLLE Ariege 09340, 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

BioFire COVID-19 Test SARS-COV-2 R-GENE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-31

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 Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Similar Registrations

Registration Number	Establishment Name	Location
3017485950	SML GENETREE CO. LTD.	Seoul, KR
3003517954	TETRACORE, INC	Potomac, MD, US
3012918440	Meridian Bioscience Canada Inc.	Quebec, CA
3024647994	Lusis Biosciences, Inc.	Hayward, CA, US
3019837962	Abbott Molecular Distribution Center	Itasca, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615778. Last updated year: 2026. Please use registration number 9615778 when referencing this establishment in official correspondence.