BEUDAMED
    FDA Registration Active 🇫🇷 France

    Diagnostica Stago - Taverny

    Reg #: 9710666 · FEI: 3003565434 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    76
    Establishment Types
    1
    Classifications
    23

    Registration Details

    Registration Name
    Diagnostica Stago - Taverny
    Registration Number
    9710666
    FEI Number
    3003565434
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23/29 rue Constantin Pecqueur
    City
    Taverny Val-d'Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K861190

    Owner / Operator

    Firm Name
    Diagnostica Stago
    Operator Number
    10023909
    Address
    3 allee Theresa
    City
    Asnieres sur Seine
    State
    Hauts-de-Seine
    Postal Code
    92600
    Country
    FR

    US Agent

    Business Name
    DIAGNOSTICA STAGO, INC
    Contact Name
    Donald KRAFT
    Address
    5 Century Dr
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US
    Email
    [email protected]
    Phone
    973 6311200 ext. 4104

    Products

    Device Name Product Code
    Test, Time, Partial Thromboplastin GGW
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Assay, Heparin KFF
    Plasma, Coagulation Factor Deficient GJT
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Plasma, Coagulation Control GGN
    Antithrombin Iii Quantitation JBQ
    Test, Time, Prothrombin GJS
    Fibrin Monomer Paracoagulation JBN
    Aggregrometer, Platelet JBX
    Calibrator, Primary JIS
    Platelet Factor 4 Radioimmunoassay LCO
    Conversion To Creatinine, Creatine JLA
    Control, Plasma, Abnormal GGC
    System, Fibrinogen Determination KQJ
    Test, Thrombin Time GJA
    Plasma, Control, Normal GIZ
    Fibrin Split Products GHH
    General Purpose Reagent PPM
    Activated Partial Thromboplastin GFO
    Bothrops Atrox Reagent JCO
    Reagent, Russel Viper Venom GIR
    Plasminogen, Antigen, Antiserum, Control DDX

    Proprietary Names

    PTT Automate STA - PTT A Asserachrom VWF:Ag STA - Heparin Control STA - VWF:Ag Calibrator FDP Plasma Latex Asserachrom D-Di FDP Plasma FDP Plasma Buffer STA - Liatest D-Di STA - Deficient VIII Pool Norm Liatest AT III STA - Staclot Protein S STA - Deficient II STA - Liatest Free Protein S STA - Neoplastine CI Plus STA - Liatest Control N + P Asserachrom Free Protein S STA - C.K. Prest C.K. Prest F.S. Test Unit Test cards for F.S. Test and FDP Plasma kits F.S. Test STA - Staclot Protein C Asserachrom b-TG STA - Stachrom Protein C STA - Quality HBPM/LMWH STA - Multi Hep Calibrator STA - Liquid Anti-Xa STA - Quality HNF/UFH STA - Hepanorm H STA - Hepanorm HBPM/LMWH Asserachrom PF4 Asserachrom IX:Ag Asserachrom Protein C Asserachrom tPA STA - Deficient X STA - Control LA 1 + 2 Fibri-Prest Automate STA - Fibrinogen Coag Control N + P STA - Deficient XI STA - Thrombin Stachrom Heparin STA - Unicalibrator Unicalibrator STA - Deficient VII STA - Deficient V D-Di Test Test cards for D-Di Test kit STA - Coag Control (N + ABN) PLUS STA - HBPM/LMWH Control Liatest Protein S System Control N + P STA - System Control N + P Asserachrom Total Protein S PTT-LA STA - Staclot Heparin Asserachrom Washing Solution STA - Deficient XII STA - Liatest VWF:Ag Staclot LA 20 Staclot LA STA - ImmunoDef VIII STA - ImmunoDef II STA - ImmunoDef IX STA - ImmunoDef XI STA - Neoplastine CI STA - Stachrom AT III STA - Reptilase STA - Deficient IX Asserachrom HPIA STA - Staclot dRVV Confirm STA - Staclot dRVV Screen STA - Stachrom Plasminogen

    Establishment Types

    Manufacture Medical Device