BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Multistix PRO® 10LS Reagent Strips

    DI: 00630414549255 · Model: 10331147 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    11
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    Multistix PRO® 10LS Reagent Strips
    Primary DI
    00630414549255
    Version / Model
    10331147
    Catalog Number
    A1554C16
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    7
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    3a6a41ca-b4c2-45a9-8ad0-4a73664ce5d9

    Device Description

    Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CEN DYE-INDICATOR, PH (URINARY, NON-QUANT.)
    JFY ENZYMATIC METHOD, CREATININE
    JIL METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
    JRE REFRACTOMETER FOR CLINICAL USE
    LJX TEST, URINE LEUKOCYTE
    JIN NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
    CDM DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
    JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
    JMT DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
    JIO BLOOD, OCCULT, COLORIMETRIC, IN URINE
    JIR INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

    GMDN Terms

    Code Name
    54514 Multiple urine analyte IVD, kit, rapid colorimetric, clinical

    Identifiers

    Type ID
    Primary 00630414549255
    Unit of Use 00630414009636

    Customer Contacts

    Phone
    +1(877)229-3711
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K992257 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not store in direct sunlight.
    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius