BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOREX LABS LLC

    Reg #: 3009469260 · FEI: 3009469260 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    BIOREX LABS LLC
    Registration Number
    3009469260
    FEI Number
    3009469260
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8041 Broadview Rd
    City
    Broadview Heights
    State
    OH
    ZIP
    44147
    Country
    US

    Owner / Operator

    Firm Name
    Biorex Labs LLC
    Operator Number
    10040313
    Address
    8041 BROADVIEW ROAD
    City
    Broadview Heights
    State
    OH
    Postal Code
    44147
    Country
    US
    Correspondent
    Evelyn R Mirza

    Products

    Device Name Product Code
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    K-CHECK DIAZO-CHEK K-CHECK CONTROLS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198