BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    AFFINITY BIOLOGICALS INC.

    Reg #: 3003485232 · FEI: 3003485232 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AFFINITY BIOLOGICALS INC.
    Registration Number
    3003485232
    FEI Number
    3003485232
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1348 SANDHILL DRIVE
    City
    ANCASTER Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K052825

    Owner / Operator

    Firm Name
    AFFINITY BIOLOGICALS INC.
    Operator Number
    9072541
    Address
    1348 SANDHILL DRIVE, --
    City
    ANCASTER
    State
    Ontario
    Postal Code
    L9G 4V5
    Country
    CA
    Correspondent
    Janet - Lepischak

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Reagents, Specific, Analyte MVU

    Proprietary Names

    VISULIZE FACTOR VIII ANTIGEN KIT Sheep anti-FXIII-IG-ASR (SAFXIII-IG-ASR-5) Sheep anti-FXIII-IG-ASR (SAFXIII-IG-ASR-500) VISULIZE FACTOR IX ANTIGEN KIT

    Establishment Types

    Manufacture Medical Device