BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    CRYOCHECK FVIII Inhibitor Kit

    Reg #: 8043599 · FEI: 3005917516 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Precision BioLogic Inc.
    Registration Number
    8043599
    FEI Number
    3005917516
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    140 Eileen Stubbs Avenue
    City
    Dartmouth Nova Scotia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K183440

    Owner / Operator

    Firm Name
    Precision BioLogic
    Operator Number
    9002573
    Address
    140 Eileen Stubbs Avenue
    City
    Dartmouth
    State
    Nova Scotia
    Postal Code
    B3B 0A9
    Country
    CA
    Correspondent
    Karen Black

    US Agent

    Business Name
    Ens Consulting Group, LLC
    Contact Name
    Gordon Ens
    Address
    224 Cedar Ridge Ct
    City
    Andover
    State
    KS
    ZIP
    67002
    Country
    US
    Email
    [email protected]
    Phone
    316 6803330

    Products

    Device Name Product Code
    Plasma, Coagulation Control GGN
    Test, Qualitative And Quantitative Factor Deficiency GGP

    Proprietary Names

    CRYOCHECK FVIII Inhibitor Kit

    Establishment Types

    Manufacture Medical Device