BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Siemens Healthcare Diagnostics, Inc.

    Reg #: 3009448641 · FEI: 3009448641 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    19

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics, Inc.
    Registration Number
    3009448641
    FEI Number
    3009448641
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    430 S Beiger St
    City
    Mishawaka
    State
    IN
    ZIP
    46544
    Country
    US

    Regulatory Submissions

    510(k) Number
    K951361

    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
    Enzymatic Method, Creatinine JFY
    Hemoglobin A1c Test System PDJ
    Assay, Glycosylated Hemoglobin LCP
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Test, Urine Leukocyte LJX
    Slide Stainer, Automated KPA
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Refractometer For Clinical Use JRE
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Calibrator, Multi-Analyte Mixture JIX
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Blood, Occult, Colorimetric, In Urine JIO
    Automated Urinalysis System KQO
    Urinalysis Controls (Assayed And Unassayed) JJW
    Blood, Occult, Enzymatic Method, In Urine JIP
    Immunoassay Method, Troponin Subunit MMI

    Proprietary Names

    Clinitek Novus Pro 12 Atellica Japan Enzymatic Creatinine (ECreJ) Pack Atellica DCA HbA1c Dx Reagent Kit DCA Systems DCA 2000+ DCA Systems HbA1c Reagent Kit DCA Systems HbA1c Controls DCA 2000 DCA HbA1c Normal and Abnormal Controls Clinistix UTI Test Strips Hematek 3000 Hema-Tek Slide Stainer Hematek Clinistix Kidney Health Test Kit CLINITEK Novus 10 Urinalysis Cassette CLINITEK Novus Calibration Kit CLINITEK Novus Automated Urine Chemistry Analyzer 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 CLINITEK family Chek-Stix Negative Control Strips Chek-Stix Chek-Stix Combo Pak Chek-Stix Control Strips Clinitek Atlas Pro 12 Reagent Pak DCA Systems M/C Controls DCA Systems Microalbumin/Creatinine DCA Systems M/C Reagent Kit Atellica™ VTLi hs-cTnI Reagent Cartridge

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device