BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DIAGNOSTICA STAGO, INC.

    Reg #: 2245451 · FEI: 2245451 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    159
    Establishment Types
    4
    Classifications
    32

    Registration Details

    Registration Name
    DIAGNOSTICA STAGO, INC.
    Registration Number
    2245451
    FEI Number
    2245451
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5 Century Dr
    City
    PARSIPPANY
    State
    NJ
    ZIP
    07054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K920943

    Owner / Operator

    Firm Name
    Diagnostica Stago, Inc.
    Operator Number
    9003476
    Address
    5 Century Drive, Sute 200
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US

    Products

    Device Name Product Code
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Assay, Heparin KFF
    Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control DBL
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Plasma, Coagulation Control GGN
    Control, Plasma, Abnormal GGC
    Test, Time, Partial Thromboplastin GGW
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Test, Time, Prothrombin GJS
    Bothrops Atrox Reagent JCO
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Activated Partial Thromboplastin GFO
    Plasma, Control, Normal GIZ
    Reagent, Russel Viper Venom GIR
    Antithrombin Iii Quantitation JBQ
    Fibrin Split Products GHH
    Fibrin Monomer Paracoagulation JBN
    Platelet Factor 4 Radioimmunoassay LCO
    Plasma, Coagulation Factor Deficient GJT
    Calibrator, Primary JIS
    Research Use Only/Immunology Devices OTR
    Calculator/Data Processing Module, For Clinical Use JQP
    Factor Xiii A, S, Antigen, Antiserum, Control DBT
    Plasminogen, Antigen, Antiserum, Control DDX
    System, Fibrinogen Determination KQJ
    Reagent & Control, Partial Thromboplastin Time GIT
    Aggregrometer, Platelet JBX
    Reagent, Platelet Aggregation GHR
    Conversion To Creatinine, Creatine JLA
    Calibrator, Secondary JIT
    Test, Thrombin Time GJA
    Instrument, Coagulation, Automated GKP

    Proprietary Names

    FDP Plasma Latex FDP Plasma FDP Plasma Buffer Stachrom Heparin Asserachrom HPIA - IgG STA - FM Control STA - Fondaparinux Control STA - Liatest D-Di STA - Control LA 1 + 2 PTT Automate 5 STA - PTT A 5 STA Satellite STA - Neoplastine CI Plus 5 STA - Neoplastine CI Plus 10 STA - System Control N + P System Control N + P STA - Reptilase STA - Staclot APC-R vWF Ag Asserachrom Free Protein S STA - Hepanorm H Staclot LA Staclot LA 20 TriniCHECK D-Dimer 1 TriniCLOT Lupus Confirm TriniCHROM Antithrombin Xa D-Di Test Test cards for D-Di Test kit STA - Stachrom Protein C Asserachrom Total Protein S STA - Liatest FM Asserachrom HPIA STA - Staclot Protein C 1 STA - Staclot Protein C 3 Unicalibrator STA - Unicalibrator STA - Deficient V STA - Quality HNF/UFH STA - Multi Hep Calibrator STA - Liquid Anti-Xa 8 STA - Quality HBPM/LMWH STA - Liquid Anti-Xa 4 STA - Dabigatran Control STA - Dabigatran Calibrator TriniCHECK D-Dimer 3 TriniCHECK D-Dimer 2 Asserachrom APA Screen Asserachrom APA IgG,M TriniCLOT Lupus Screen Liatest AT III STA - Liatest Free Protein S 2 STA - Liatest Free Protein S 6 STA Coag Expert STA Coag Connexion SCE upgrade to Coag.One server license Coag.One server license TriniCLOT aPTT S 10 ml TriniCLOT aPTT S 3 ml STA-R Evolution/Expert Series(XP)/E5 + cap piercing STA-R Evolution/Expert Series(XP)/E5 STA R Max + cap piercing STA R Max Asserachrom D-Di K-ASSAY FACTOR XIII K-ASSAY FACTOR XIII CALIBRATOR K-ASSAY FACTOR XIII CONTROL TriniCHROM Antithrombin IIa STA - Staclot Heparin 1 STA - NeoPTimal 5 STA - NeoPTimal 20 STA - NeoPTimal 10 STA - Stachrom Plasminogen STA - VWF:Ag Calibrator Asserachrom PF4 TriniCLOT Calcium Chloride 025 M STA Compact Max + cap piercing STA Compact Max TriniLIZE PAI-1 Activity STA - Deficient VIII Liatest Protein S STA - Deficient X TriniCLOT Factor X STA - Heparin Control PTT-LA TriniCLOT Thrombin Time TriniCLOT Factor VII STA - ImmunoDef VIII STA - ImmunoDef XII STA - ImmunoDef IX STA - ImmunoDef II STA - ImmunoDef XI KC1 TriniCHROM Factor VIII:C TriniCLOT PT Excel S 6 ml TriniCLOT PT Excel S 20 ml TriniCAL Reference Plasma TriniCHECK Abnormal Control STA - Staclot dRVV Screen 2 STA - Staclot dRVV Confirm STA - Staclot dRVV Screen 5 STA - Deficient XI TriniCLOT Factor IX Destiny Plus STA - Deficient VII STA - Stachrom AT III 3 STA - Stachrom AT III 6 TriniCLOT aPTT HS 10 ml TriniCLOT aPTT HS 3 ml F.S. Test F.S. Test Unit Test cards for F.S. Test and FDP Plasma kits Asserachrom tPA STA - Liatest VWF:Ag STA - HBPM/LMWH Control TriniCLOT Factor II Asserachrom b-TG TriniCLOT Factor XI KC4 Asserachrom VWF:Ag STA Satellite Max STA - Coag Control (N + ABN) PLUS Asserachrom VWF:FVIIIB Stachrom PAI Asserachrom VWF:CB STA - VWF:Rco Destiny Max TriniCLOT Factor VIII TriniCLOT Factor XII Ristocetin STA - Hepanorm HBPM/LMWH Asserachrom Protein C STA - Deficient IX TriniLIZE PAI-1 Antigen TriniCHECK Lupus Positive Control TriniLIA D-Dimer STA - FM Calibrator TriniCAL INR & Quick STA - Fondaparinux Calibrator Etaloquick STA - Deficient XII STA - Thrombin 10 STA - Thrombin 2 STA - Liatest Control N + P Pool Norm STA - Staclot Protein S TriniCLOT Fibrinogen TriniCLOT Fibrinogen Kit TriniCAL Fibrinogen TriniCLOT Imidazole Buffer ST art TriniLIA Auto Dimer Saline STA Compact MAX 3 STA R Max 3 TriniCLOT Factor V STA - Deficient II C.K. Prest 5 STA - C.K. Prest 5 C.K. Prest 2 Asserachrom IX:Ag

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198