BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Multistix Pro 10LS 100

    Reg #: 3002637618 · FEI: 3002637618 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc
    Registration Number
    3002637618
    FEI Number
    3002637618
    Status
    Active
    Expiry Year
    2025
    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
    K992257

    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
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Test, Urine Leukocyte LJX
    Enzymatic Method, Creatinine JFY
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Blood, Occult, Colorimetric, In Urine JIO
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Refractometer For Clinical Use JRE
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN

    Proprietary Names

    Multistix Pro 10LS 100 Multistix Multistix 10 Combistix SG reagent strips N-Multistix SG reagent strips N-Labstix reagent strips Uristix Multistix Reagent Strip Family Hemacombistix Multistix 7 Multistix 10 SG Reagent Strips Uristix 4 Labstix Labstix SG reagent strips Multistix GP reagent strips Multistix Pro 10LS 25 Multistix Reagent Strips Microalbustix reagent strips Multistix Pro Reagent Strip Family Multistix 8 SG Albustix Acetest Reagent Tablets Multistix 9 SG AZO Test Strips Combistix Multistix 9 Multistix SG Family Hemastix Azostix Multistix 5 Q-ity™ UA 10 Visual Urine Strips

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility