BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOMERIEUX, INC.

    Reg #: 3002769706 · FEI: 3002769706 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    20
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    BIOMERIEUX, INC.
    Registration Number
    3002769706
    FEI Number
    3002769706
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    100 RODOLPHE ST
    City
    DURHAM
    State
    NC
    ZIP
    27712
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021123

    Owner / Operator

    Firm Name
    BIOMERIEUX SA
    Operator Number
    8020790
    Address
    Chemin De L Orme
    City
    Marcy L Etoile
    State
    Rhone
    Postal Code
    69280
    Country
    FR

    Products

    Device Name Product Code
    System, Blood Culturing MDB
    System, Detection, Bacterial, For Platelet Transfusion Products MZC
    Blood And Urine Collection Kit (Excludes Hiv Testing) OIB

    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 FN PLUS BacT/ALERT FN (Plastic Bottles) BACT/ALERT PF PLUS CULTURE BOTTLE BacT/ALERT FA Plus BacT/ALERT PF Plus BacT/ALERT SA (Plastic Bottles)

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility