Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002769706

FEI Number

3002769706

Entity Name

BIOMERIEUX, INC.

City/State/Country

DURHAM, NC, US

Establishment Address

100 RODOLPHE ST, DURHAM, NC 27712, US

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

BK050043

PMA Number

N/A

All Registered Proprietary Names

BacT/ALERT SN (Plastic Bottles) BACT/ALERT BPN Culture Bottle BACT/ALERT BPA Culture Bottle BacT/ALERT FA (Plastic Bottle) BACT/ALERT MP Reagent System BacT/ALERT PF (Plastic Bottles) BIOMERIEUX WORKSAFE Blood Culture Collection Kit : Charcoal BIOMERIEUX WORKSAFE Blood Culture Collection Kit : Charcoal Pediatric BIOMERIEUX WORKSAFE Blood Culture Collection Kit : FAN® PLUS Pediatric BIOMERIEUX WORKSAFE Blood Culture Collection Kit : Standard BIOMERIEUX WORKSAFE Blood Culture Collection Kit : Charcoal Combo BIOMERIEUX WORKSAFE Blood Culture Collection Kit : FAN® PLUS BIOMERIEUX WORKSAFE Blood Culture Collection Kit : FAN® PLUS Combo BACT/ALERT FA PLUS CULTURE BOTTLE BACT/ALERT BPN Culture Bottle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-27
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2020-09-08
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-27
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2019-05-16
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-27
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2018-03-19
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2013-01-30
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2020-04-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin
Z-0028-2014	Becton Dickinson & Co. BD Diagnostic Systems	1	BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

Similar Registrations

Registration Number	Establishment Name	Location
2647876	BECTON DICKINSON CARIBE LTD.	CAYEY, PR, US
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
1111096	BECTON, DICKINSON & CO.	Cockeysville, MD, US
3031977134	bioMerieux, Inc.	Morrisville, NC, US
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002769706. Last updated year: 2026. Please use registration number 3002769706 when referencing this establishment in official correspondence.