BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Procleix® WNV/Babesia Quality Control

    Reg #: 2032600 · FEI: 3003460312 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Grifols Diagnostic Solutions Inc.
    Registration Number
    2032600
    FEI Number
    3003460312
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10808 WILLOW CT.
    City
    SAN DIEGO
    State
    CA
    ZIP
    92127
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK220746

    Owner / Operator

    Firm Name
    Grifols Diagnostic Solutions Inc.
    Operator Number
    10051675
    Address
    4560 Horton Street
    City
    Emeryville
    State
    CA
    Postal Code
    94608
    Country
    US

    Products

    Device Name Product Code
    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. QTM

    Proprietary Names

    Procleix® WNV/Babesia Quality Control

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device