BIOMERIEUX SA

Entity profile compiled from public source records

Public Record Profile Registrations: 16 510(k) filings: 0 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000351505, 1000611339, 1450405, 1950204, 3002769706, 3002773840, 3003261083, 3007808629, 3008237827, 3008249922, 3009307598, 3010770794, 3013394941, 3023036790, 3025775667, 3031977134
Owner Operator Numbers 8020790
Locations Covered CRAPONNE Rhone, FR; Combourg Ille-et-Vilaine, FR; DURHAM, NC, US; Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR; HAZELWOOD, MO, US; LA BALME LES GROTTES Isere, FR; LOMBARD, IL, US; MARCY L ETOILE Rhone, FR; Morrisville, NC, US; PONTE-A EMA, FLORENCE Firenze, IT; Salt Lake City, UT, US; San Jose, CA, US; Tres Cantos Madrid (Province), ES; VERNIOLLE Ariege, FR

Registered Establishments (16)

Registration # Establishment Name Location Establishment Type(s) Action
1450405 BIOMERIEUX, INC. LOMBARD, IL, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1950204 BIOMERIEUX, INC. HAZELWOOD, MO, US Manufacture Medical Device View Details
3002769706 BIOMERIEUX, INC. DURHAM, NC, US Manufacture Medical Device View Details
3002773840 BioFire Diagnostics, LLC Salt Lake City, UT, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3008249922 BIOMERIEUX SA - Grenoble Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR Manufacture Medical Device View Details
3009307598 BIOMERIEUX SPAIN Tres Cantos Madrid (Province), ES Manufacture Medical Device View Details
3010770794 BioFire Defense, LLC Salt Lake City, UT, US Manufacture Medical Device View Details
3013394941 BIOMERIEUX SA Combourg Ille-et-Vilaine, FR Manufacture Medical Device View Details
3023036790 Specific Diagnostics San Jose, CA, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3025775667 BIOMERIEUX, INC. Salt Lake City, UT, US Complaint File Establishment per 21 CFR 820.198 View Details
3031977134 bioMerieux, Inc. Morrisville, NC, US Complaint File Establishment per 21 CFR 820.198 View Details
8020790 BIOMERIEUX SA MARCY L ETOILE Rhone, FR Export Device to the United States But Perform No Other Operation on Device View Details
9615037 BIOMERIEUX ITALIA-INDUSTRIAL DIV. PONTE-A EMA, FLORENCE Firenze, IT Manufacture Medical Device View Details
9615754 BIOMERIEUX SA LA BALME LES GROTTES Isere, FR Manufacture Medical Device View Details
9615755 BIOMERIEUX FRANCE CRAPONNE Rhone, FR Manufacture Medical Device View Details
9615778 BioMerieux SA VERNIOLLE Ariege, FR Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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