BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Precision BioLogic Inc.

    Reg #: 8043599 · FEI: 3005917516 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    Precision BioLogic Inc.
    Registration Number
    8043599
    FEI Number
    3005917516
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    140 Eileen Stubbs Avenue
    City
    Dartmouth Nova Scotia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K971227

    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 Factor Deficient GJT
    Reagent, Russel Viper Venom GIR
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Plasma, Coagulation Control GGN
    Control, Plasma, Abnormal GGC
    Activated Partial Thromboplastin GFO
    Test, Time, Partial Thromboplastin GGW
    Plasma, Control, Normal GIZ

    Proprietary Names

    CRYOCHECK Factor X Deficient Plasma CRYOCHECK LA Sure CRYOCHECK Factor XI Deficient Plasma CRYOCHECK FVIII Inhibitor Kit CRYOCHECK Factor V Deficient Plasma CRYOCHECK Abnormal 1 Reference Control CRYOCHECK Abnormal 2 Reference Control CRYOCHECK Low Fibrinogen Control Cryocheck Hex LA CRYOCHECK Platelet Lysate Cryocheck Chromogenic Factor VIII CRYOCHECK Normal Reference Plasma CRYOCHECK Lupus Positive Control CRYOCHECK Abnormal 2 Control CRYOCHECK Pooled Normal Plasma CRYOCHECK Abnormal 1 Control CRYOCHECK Factor XII Deficient Plasma CRYOCHECK Clot C Cryocheck Lupus Negative Control CRYOCHECK Weak Lupus Positive Control CRYOCHECK Prekallikrein Deficient Plasma CRYOCHECK LA Check CRYOCHECK Reference Control Normal CRYOCHECK Factor VII Deficient Plasma CRYOCHECK Factor II Deficient Plasma CRYOCHECK APCR Positive Control CRYOcheck Chromogenic Factor VIII CRYOcheck Factor VIII Deficient Plasma with VWF CRYOcheck Chromogenic Factor IX CRYOCHECK Factor VIII Deficient Plasma CRYOCHECK Factor IX Deficient Plasma

    Establishment Types

    Manufacture Medical Device