BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cholestech LDX™

    DI: 00893038002883 · Model: 97986 · ALERE SAN DIEGO, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cholestech LDX™
    Primary DI
    00893038002883
    Version / Model
    97986
    Catalog Number
    97986
    Company Name
    ALERE SAN DIEGO, INC.
    Labeler DUNS
    194854949
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-20
    Public Version
    1
    Public Version Date
    2023-12-28
    Public Version Status
    New
    Public Device Record Key
    d8f8681f-a945-449c-90f6-94dd6967afec

    Device Description

    Cholestech LDX™ TC

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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

    GMDN Terms

    Code Name
    53357 Multiple lipid analyte IVD, reagent

    Identifiers

    Type ID
    Primary 00893038002883

    Customer Contacts

    Phone
    +18774417440
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K223179 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius