BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile

    DI: 00887473000344 · Model: 02LS10B · SD Biosensor, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile
    Primary DI
    00887473000344
    Version / Model
    02LS10B
    Company Name
    SD Biosensor, Inc.
    Labeler DUNS
    557812789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2023-05-10
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    61a62bba-9d53-4722-ada1-5a039b74bb9c

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CHH Enzymatic Esterase--Oxidase, Cholesterol
    JGY Colorimetric Method, Triglycerides
    LBR Ldl & Vldl Precipitation, Hdl

    GMDN Terms

    Code Name
    53359 Total cholesterol lipid IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Unit of Use 00887473000313
    Primary 00887473000344

    Premarket Submissions

    Submission Number Supplement Number
    K160282 000