BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Siemens Healthcare Diagnostics Products GmbH

    Reg #: 9610806 · FEI: 3001644026 · Expires 2026
    View on FDA
    Products
    80
    Proprietary Names
    290
    Establishment Types
    4
    Classifications
    80

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Products GmbH
    Registration Number
    9610806
    FEI Number
    3001644026
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    76 EMIL-VON-BEHRING STRASSE
    City
    MARBURG Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K083159

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US

    US Agent

    Business Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Contact Name
    Mary Seeger
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US
    Email
    [email protected]
    Phone
    914 3254329

    Products

    Device Name Product Code
    Control, Plasma, Abnormal GGC
    Plasma, Control, Normal GIZ
    System, Multipurpose For In Vitro Coagulation Studies JPA
    System, Test, Rheumatoid Factor DHR
    Iga, Antigen, Antiserum, Control CZP
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Radioimmunoassay, Immunoglobulins (G, A, M) CFQ
    Igg, Antigen, Antiserum, Control DEW
    System, Test, C-Reactive Protein, Rhodamine DCH
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Multi-Analyte Mixture JIX
    Transferrin, Antigen, Antiserum, Control DDG
    Assay, Heparin KFF
    Alpha-1-Antitrypsin, Antigen, Antiserum, Control DEM
    Plasma, Coagulation Factor Deficient GJT
    Test, Carbohydrate Deficient Transferrin NAO
    Test, Cystatin C NDY
    Method, Nephelometric, Immunoglobulins (G, A, M) CFN
    Bothrops Atrox Reagent JCO
    Lambda, Antigen, Antiserum, Control DEH
    Kappa, Antigen, Antiserum, Control DFH
    Test, Heparin Neutralization JBR
    Antithrombin Iii Quantitation JBQ
    Igg (Fc Fragment Specific), Antigen, Antiserum, Control DAS
    System, Test, Beta-2-Microglobulin Immunological JZG
    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD
    Igg (Gamma Chain Specific), Antigen, Antiserum, Control DFZ
    Anti-Factor Xa Activity Test System, Apixaban QLU
    Plasma, Coagulation Control GGN
    Nephelometer JZW
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Plasminogen, Antigen, Antiserum, Control DDX
    System, Automated Platelet Aggregation JOZ
    Calibrator, Primary JIS
    Albumin, Antigen, Antiserum, Control DCF
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Ferritin, Antigen, Antiserum, Control DBF
    Test, Sickle Cell GHM
    Prothrombin Fragment 1.2 MIF
    Detergent JCB
    Test, Thrombin Time GJA
    Test, Time, Partial Thromboplastin GGW
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Fibrinogen Determination Standards And Controls GFK
    Ige, Antigen, Antiserum, Control DGC
    Test, Time, Prothrombin GJS
    Reagent, Russel Viper Venom GIR
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Fibrinogen Standard GFX
    System, Test, C-Reactive Protein DCN
    Activated Partial Thromboplastin GFO
    System, Fibrinogen Determination KQJ
    Hemopexin, Antigen, Antiserum, Control CZX
    Complement C3, Antigen, Antiserum, Control CZW
    Complement C4, Antigen, Antiserum, Control DBI
    Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control LKL
    Haptoglobin, Antigen, Antiserum, Control DAD
    Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control DBA
    Von Willebrand Factor Assay QTY
    Slide Stainer, Automated KPA
    Alpha-2-Macroglobulin, Antigen, Antiserum, Control DEB
    Prealbumin, Antigen, Antiserum, Control JZJ
    Apolipoproteins MSJ
    Alpha-Globulin, Antigen, Antiserum, Control DCO
    Calibrator, Secondary JIT
    Myoglobin, Antigen, Antiserum, Control DDR
    Ph Buffer JCC
    Ceruloplasmin, Antigen, Antiserum, Control DDB
    Plasma, Fibrinogen Control GIL
    Reagent & Control, Partial Thromboplastin Time GIT
    Immunochemical, Ceruloplasmin CHN
    Urinary Homocystine (Nonquantitative) Test System LPS
    Antithrombin Iii, Two Stage Clotting Time Assay JPE
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Retinol-Binding Protein, Antigen, Antiserum, Control CZS
    Control, Hemoglobin GGM
    Antideoxyribonuclease, Streptococcus Spp. GTR
    Instrument, Coagulation, Automated GKP
    Radioimmunoassay (Two-Site Solid Phase), Ferritin JMG

    Proprietary Names

    Berichrom Heparin LMW Control 1 Berichrom Heparin LMW Calibrator Berichrom Heparin LMW Control 2 N Latex RF Kit N Latex IgA BN II Evaporation Stoppers N Cuvettes Segments for BN II BN II System IMMULITE Probe Wash Module IMMULITE Probe Cleaning Kit IMMULITE 2000 / XPi Probe Cleaning Kit IMMULITE 2000 / XPi Probe Wash Module TRF, PROT3 CON Dade Ci-Trol Heparin Control, Low Dade Ci-Trol Heparin Control, High N Antiserum to Human a1-Antitrypsin Dimension Vista sTFR Flex N Protein Standard PY Clotting Factor V Deficient Plasma Dimension Vista CDT Flex N Latex Cystatin C N Latex IgM Batroxobin Reagent Dimension Vista KAPPA Flex Dimension Vista PROT1 CON H Dimension Vista LAMBDA Flex Dade Hepzyme N Latex FLC kappa N Latex FLC lambda Enzygnost TAT micro N AS IgG1 N AS IgG3 N AS IgG4 N AS IgG2 N a1-Microglobulin Kit Coag Factor XI Deficient Plasma Coag Factor IX Deficient Plasma Coag Factor VIII Deficient Plasma Coag Factor XII Deficient Plasma Dimension Vista hsCRP Control L Dimension Vista hsCRP Control H Dimension Vista hsCRP Felx Dimension Vista IGG3 Flex Dimension Vista IGG4 Flex Dimension Vista IGG1 Flex Dimension Vista IGG2 Flex Vista PROT1 Cal Vista PROT1 CON M Vista PROT1 CON L Vista B2MIC Flex INNOVANCE Apixaban Controls INNOVANCE Apixaban Standards INNOVANCE Anti-Xa ProC Control Plasma Control Plasma N N Apolipoprotein Standard Serum BN II Additive N Predilution Wells N Evaporation Caps for Control Vials (2.5 mL) BN ProSpec System CLEANER SCS N Cuvettes Segments for BN ProSpec Factor VIII Chromogenic Assay Berichrom Plasminogen Dade Cluster Platelet Aggregation Reagents INNOVANCE Heparin Calibrator INNOVANCE Heparin LMW Control 2 INNOVANCE Heparin UF Control 1 INNOVANCE Heparin INNOVANCE Heparin LMW Control 1 INNOVANCE Heparin UF Control 2 Dimension Vista sALB Flex reagent cartridge (sALB) Atellica CH Urine Albumin (UAlb) INNOVANCE D-Dimer Controls INNOVANCE D-Dimer Sample Diluent N Latex Ferritin Behring Coagulation Cup vWF Ag Sickle-Sol Tests Enzygnost F1+2 monoclonal Berichrom Protein C Dimension Vista A1AT Flex Atellica CH Alpha-1-Antitrypsin 2 (AAT2) ADVIA 2120 and ADVIA 2120i Aspiration pathway Wash Kit ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash Kit Neodisher GK ADVIA 2120 and ADVIA 2120i Perox Flow cell wash kit ADVIA 2120 and ADVIA 2120i Vent Line Wash Kit BC Thrombin Reagent Factor V Leiden QuikLYTE IMT Std A QuikLyte IMT Std B Dimension Sample Cups with Lids Dimension CA Flex Dimension BUN Flex Dimension CHEM I Cal Purified Water Diluent Dimension Enzyme Verifier Dimension Cuvette Cartridge Dimension Salt Bridge Solution Apolipoprotein Control Serum CHD Dade Fibrinogen Determination Reagents Berichrom Heparin UF Calibrator Berichrom Heparin UF Control 1 Berichrom Heparin UF Control 2 Atellica CH Protein 1 Calibrator (PROT1 CAL) Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL) Atellica CH Bilirubin Calibrator (BILI CAL) N Latex FLC Lambda N Latex FLC Kappa Standard Human Plasma N Latex IgE mono N Latex CDT Kit N Antiserum to Human-Ig/L-chain, λ type N Antiserum to Human-Ig/L-chain, k type N/T Rheumatology Control SL/2 N/T Rheumatology Control SL/1 RapiTex RF INNOVANCE Free PS Ag Dade Innovin Dimension Vista PROT3 Cal Berichrom a2-Antiplasmin Dade Actin FS Activated PTT Reagent Dade PFA Trigger Solution Dade PFA Priming Cartridges PFA-100 System Dade PFA Vacuum Cups Dade PFA Collagen/ADP Test Cartridges Dade PFA Collagen/EPI Test Cartridges Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) BCS XP System BCS System Cuvette Rotors BC Vial Kit LA 2 Confirmation Reagent LA 1 Screening Reagent N Lp (a) Control SY N Antiserum to Human Transferrin N Latex B2-Microglobulin Berichrom Heparin Fibrinogen Calibrator Kit CardioPhase hsCRP N Latex ASL Dimension Vista ASL Flex Atellica CH Anti-Streptolysin-O_2 (ASO_2) Atellica CH Anti-Streptolysin-O_3 (ASO_3) ADVIA Chemistry Dade Actin Activated Cephaloplastin Reagent Multifibren U Dimension Vista IGE Flex N Antiserum to Human Hemopexin Dimension Vista HPX Flex Protein C Reagent INNOVANCE D-Dimer BC von Willebrand Reagent Dimension Vista C4 Flex Dimension Vista C3 Flex Dimension Vista A1AG Flex Atellica CH Alpha-1-acid Glycoprotein (AAG) Dimension Vista HAPT Flex Atellica CH Haptoglobin_2 (Hapt_2) ADVIA Chemistry HAPT N Lp (a) Standard SY N Rheumatology Standard SL N Antiserum to Human C1 Inhibitor INNOVANCE VWF Ac N FLC Standard SL N FLC Supplementary Reagent N FLC Control SL1 N FLC Control SL2 Hematek 3000 Hema-Tek Slide Stainer Hematek Dade Ci-Trol Coagulation Control Level 1 N Antiserum to Human-a2-Macroglobulin Dimension Vista PREALB Flex N Antiserum to Human Prealbumin Atellica CH Prealbumin (PALB) Dimension Vista APO Control Dimension Vista APO Cal Dimension Vista APOAI Flex Dimension Vista APOB Flex N Antiserum to Human C3c N Antiserum to Human C4 Dimension Vista A1MIC Flex N Protein Standard UY N Antisera to Human IgM N Antisera to Human IgA N Antisera to Human IgG Advanced D-Dimer Standard Plasma Advanced D-Dimer Control Plasma 2 Advanced D-Dimer Control Plasma 1 N Latex Myoglobin Washing Solution for Coagulation Analyzers Imidazole Buffer Solution Blood Gas Systems Buffer Dimension Vista CYSC Control H Dimension Vista CYSC Control L Dimension Vista CYSC Flex N Antiserum to Human Ceruloplasmin BFT II Analyzer "Dispo System" Cuvettes for BFT II Analyzer BFT II Analyzer Printer Paper for BFT II N/T Protein Control PY Dimension Vista CER Flex INNOVANCE Antithrombin N Antiserum to Human Albumin Dimension Vista HCYS Flex N Antisera to Human Immunoglobulins (IgA) N Antisera to Human Immunoglobulins (IgM) Thromborel S Dade Thrombin Reagent Owren's Veronal Buffer Dade CA System Buffer Dimension Vista PROT2 Control H Dimension Vista PROT2 Cal Dimension Vista PROT2 Control L Test Thrombin Reagent Berichrom Antithrombin III (A) N Latex Lp(a) Reagent Control Plasma P Protein S Ac Dade Actin FSL Activated PTT Reagent Dimension Vista A2MAC Flex N Antiserum to Human RbP Dimension Vista RBP Flex Dimension Vista CDT CON L Dimension Vista CDT CON H Dimension Vista CDT Cal Dade Ci-Trol Coagulation Control Level 3 Dade Ci-Trol Coagulation Control Level 2 Pathromtin SL Sickle-Trol Hemoglobin Control Dimension Vista CRP Flex Dimension Vista MALB Flex Xprecia System PT Controls Dade Data-Fi Abnormal Control Dimension Vista C1IN Cal Dimension Vista C1IN Con Dimension Vista C1IN Flex ADVIA Chemistry Cystatin C_2 Calibrator Atellica CH Cystatin C Calibrators (CysC CAL) Atellica CH Microalbumin_2 Calibrator (?ALB_2 CAL) Dimension Vista Chemistry 1 Calibrator Atellica CH Toxicology Calibrator (TOX CAL) Dimension Vista Thyroxine/Thyronine-Uptake Calibrator Atellica CH Special Chem CAL (SPCL CHEM CAL) Atellica CH Liquid Specific Protein Calibrators (LSP CAL) Atellica CH Protein 2 Calibrator (PROT2 CAL) N Antisera to Human IgG, IgA, IgM N/T Protein Control LC LA Control Low LA Control High Dimension Vista RF Flex N Protein Standard SL N/T Protein Control SL/H N/T Protein Control SL/M N/T Protein Control SL/L N Latex HCY Kaolin Suspension N Latex ADNase B BC Validation Kit Calcium Chloride Solution N Antiserum to Human a1-acid Glycoprotein N Diluent N Antiserum to Human Antithrombin III N Antiserum to Human Haptoglobin N Supplementary Reagent/Precipitation N Antiserum to Human Fibrinogen N Antiserum to Human Apolipoprotein B N Antiserum to Human Apolipoprotein A-I N Reaction Buffer N Antiserum to Human Plasminogen Dimension Vista IGA Flex Dimension Vista IGM Flex RapiTex CRP Dimension Vista IGG Flex Coag Factor II Deficient Plasma Coag Factor VII Deficient Plasma Coag Factor X Deficient Plasma Dimension Sample Probe Cleaner Dimension Reagent Probe Cleaner Dimension Reaction Vessels Dimension® HM Dimension IMT Probe Cleaner Dimension FERR Flex Dimension Chemistry Wash Dimension Sample Diluent N Latex sTfR N Supplementary Reagent L

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198