BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Siemens Healthcare Diagnostics Inc

    Reg #: 3002637618 · FEI: 3002637618 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    186
    Establishment Types
    4
    Classifications
    59

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc
    Registration Number
    3002637618
    FEI Number
    3002637618
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Point Of Care Headquarters, 333 Coney St
    City
    East Walpole
    State
    MA
    ZIP
    02032
    Country
    US

    Regulatory Submissions

    510(k) Number
    K870036

    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

    Products

    Device Name Product Code
    Controls For Blood-Gases, (Assayed And Unassayed) JJS
    Reagent, Occult Blood KHE
    Blood, Occult, Colorimetric, In Urine JIO
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Refractometer For Clinical Use JRE
    Test, Urine Leukocyte LJX
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Automated Urinalysis System KQO
    Enzymatic Method, Creatinine JFY
    Calibrator, Secondary JIT
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Myoglobin, Antigen, Antiserum, Control DDR
    Immunoassay Method, Troponin Subunit MMI
    Fluorometric Method, Cpk Or Isoenzymes JHX
    Blood, Occult, Enzymatic Method, In Urine JIP
    Tetrabromo-M-Cresolsulfonphthalein, Albumin CJG
    System, Test, Vitamin D MRG
    Calibrator, Multi-Analyte Mixture JIX
    Visual, Pregnancy Hcg, Prescription Use JHI
    Fluorometer, For Clinical Use KHO
    System, Test, Immunological, Antigen, Tumor MOI
    Test, Natriuretic Peptide NBC
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Acid, Lactic, Enzymatic Method KHP
    Glucose Oxidase, Glucose CGA
    Electrode, Ion Specific, Calcium JFP
    System, Hemoglobin, Automated GKR
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Ige, Antigen, Antiserum, Control DGC
    System, Test, Human Chorionic Gonadotropin DHA
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Pressure, Gas BXX
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Calculator/Data Processing Module, For Clinical Use JQP
    Assay, Glycosylated Hemoglobin LCP
    Container, Specimen, Non-Sterile NNI
    Control, Hematocrit GLK
    Regulator, Pressure, Gas Cylinder CAN
    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD
    Instrument, Hematocrit, Automated GKF
    Gas, Calibration (Specified Concentration) BXK
    Urinalysis Controls (Assayed And Unassayed) JJW
    Fluorometric, Cortisol JFT
    Enzyme Immunoassay, Digoxin KXT
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Fibrin Split Products GHH
    Hepatitis A Test (Antibody And Igm Antibody) LOL
    Standards And Controls, Hemoglobin, Normal And Abnormal GFS
    Tube, Collection, Capillary Blood GIO

    Proprietary Names

    RapidQC Plus Blood Gas Systems Controls Hema-Chek CLINITEK Family (500, 200, 100) CLINITEK Advantus Hemastix Stratus CS CTNI CalPak Rapidpoint 400/405/500 systems Pleural Fluid Stratus CS Acute Care MYO TestPak Stratus CS Acute Care CKMB TestPak Stratus CS Acute Care CTNI CalPak Stratus CS Acute Care CKMB CalPak Stratus CS Acute Care CTNI TestPak Stratus CS Acute Care MYO CalPak SCS CKMB CalPak SCS Rotors SCS Cannula (BD) SCS Cannula (Sarstedt) SCS Printer Paper SCS Sample Cup SCS Pipette Tips SCS Cannula (Terumo) Stratus CS Analyzer SCS Waste Bin Liner Clinitek Atlas Pro 12 Reagent Pak CLINITEK Microalbumin Reagent Strip CLINITEK Microalbumin 2 Reagent ADVIA Centaur Vitamin D Total (VitD) Atellica IM Vitamin D Total (VitD) CLINITEK Novus 10 Urinalysis Cassette CLINITEK Novus Calibration Kit CLINITEK Novus Automated Urine Chemistry Analyzer Clinitest hCG SCS CKMB DilPak ADVIA Centaur BR Assay (BR) Atellica IM BR 27.29 (BR) SCS CTNI DilPak Stratus CS Acute Care PBNP TestPak RAPIDPoint® 500e Blood Gas System iCa++ Quick Sampler Atellica IM Total IgE Diluent (tIgE DIL) Atellica IM Total IgE (tIgE) Stratus CS BHCG TestPak Stratus CS BHCG CalPak Stratus CS Acute Care DDMR CalPak Stratus CS Acute Care DDMR TestPak SCS MYO CalPak SCS MYO TestPak Clinistix Kidney Health Test Kit RapidQC CVM ADVIA Centaur NT-proBNP Master Curve Material (PBNP MCM) Atellica IM VitDII Quality Control (VitDII QC) ADVIA Centaur Lipopolysaccharide Binding Protein Quality Control (LBP QC) Regulator Cal Gas Gas Cartridge Pak Slope Gas 10%CO2 Bal N2 Cal Gas 5% 12% O2 ADVIA Centaur TSH3-Ultra (TSH3ULII) Atellica IM TSH3-Ultra (TSH3ULII) POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite RAPIDPOINT 405 Rapidpoint 400 Series Blood Gas Systems Family Atellica IM Vitamin D Total II (VitDII) Atellica IM VitDII Diluent (VitDII DIL) Stratus CS DDMR TestPak DCA Systems DCA 2000+ DCA Systems HbA1c Reagent Kit DCA Systems HbA1c Controls DCA 2000 DCA HbA1c Normal and Abnormal Controls Ictotest Stratus CS D-Dimer TestPak DDMRE Clinitek Status+ Clinitek Status CT Status CT Status+ Urin-Tek, Urine Collection System RapidQC Hct 800 SERIES M860 Clinitek Novus Positive Control Strips Atlas Negative Control Clinitek Atlas 12 Atlas Cal Kit Atlas Clarity Calibrator Atlas Positive Control Clinitek Atlas CLINITEK Atlas Carosel Clinitek Family CLINITEK Atlas Rack Clinitek Atlas 10 Clinitek Novus Negative Control Strips Clinistix UTI Test Strips REGULATOR. PRESSURE GAS CYLINDER RapidLab 1200 nBili Activation Key Stratus CS Acute Care CCRP TestPak Rapidpoint 400 Rapidpoint Blood Gas Stratus CS Acute Care PBNPM CalPak Stratus CS Acute Care BHCG CalPak Stratus CS Acute Care BHCG TestPak Stratus CS Acute Care PBNP CalPak Microalbustix reagent strips AZO Test Strips Multistix GP reagent strips Multistix Reagent Strip Family N-Multistix SG reagent strips Multistix 5 Acetest Reagent Tablets N-Labstix reagent strips Multistix SG Family Hemacombistix Uristix Multistix 7 Uristix 4 Labstix Albustix Combistix SG reagent strips Combistix Multistix 9 Multistix 10 SG Reagent Strips Multistix 8 SG Multistix Pro 10LS 100 Multistix Labstix SG reagent strips Multistix Pro 10LS 25 Multistix Reagent Strips Multistix 9 SG Multistix 10 Azostix Multistix Pro Reagent Strip Family Q-ity™ UA 10 Visual Urine Strips GAS, CALIBRATION (SPECIFIED CONCENTRATION (Cal Gas) DCA Systems M/C Controls DCA Systems Microalbumin/Creatinine DCA Systems M/C Reagent Kit Stratus CS Acute Care CCRP CalPak Chek-Stix Chek-Stix Combo Pak Chek-Stix Control Strips CLINITEK family ADVIA Centaur B-type Natriuretic Peptide (BNP) Atellica IM B-type Natriuretic Peptide (BNP) Atellica IM Cortisol (Cor) ADVIA Centaur Cortisol (Cor) Atellica IM Digoxin (DIG) ADVIA Centaur Digoxin (DIG) Chek-Stix Negative Control Strips Rapidpoint 500 MCart with calibrator RP500 MCart calibrator DCA Vantage Rapidpoint 500 System Lactate MulltiCap capillaries Rapidlab 1200 Rapidlab Blood Gas Systems Rapidlab 800 Series Rapidlab 1200 Series Stratus CS DDMR CalPak Rapidlab 348 ADVIA Centaur Hepatitis A IgM (aHAVM) Atellica IM Hepatitis A IgM (aHAVM) RapidQC Complete RapidQC CVM RAPIDPOINT 500 Atellica IM Hepatitis A Total (HAVT) ADVIA Centaur Hepatitis A Total (HAVT) DCA Systems Hemoglobin A1c Normal and Abnormal Controls ADVIA Centaur Follicle Stimulating Hormone Master Curve Material (FSH MCM) Atellica IM Follicle Stimulating Hormone Master Curve Material (FSH MCM) Multicap Blood Collection Capillaries Capillary Caps Luer Capillary Blood Gas Blood Collection Capillary Tubes Plastic Capillaries 248 BG System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Device in the United States for Export Only