BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alere Cholestech LDX®

    DI: 00899722002337 · Model: 99020 · ALERE SAN DIEGO, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alere Cholestech LDX®
    Primary DI
    00899722002337
    Version / Model
    99020
    Catalog Number
    99020
    Company Name
    ALERE SAN DIEGO, INC.
    Labeler DUNS
    194854949
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-29
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f478be02-1880-41e3-9496-b299276a1ff7

    Device Description

    Alere Cholestech LDX® Lipid Profile

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    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
    JGY Colorimetric Method, Triglycerides
    LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
    CHH Enzymatic Esterase--Oxidase, Cholesterol

    GMDN Terms

    Code Name
    52850 Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

    Identifiers

    Type ID
    Primary 00899722002337

    Customer Contacts

    Phone
    +18773088289
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius