BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    JAS Diagnostics

    DI: 00817274021729 · Model: LIPC1-3 · DREW SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JAS Diagnostics
    Primary DI
    00817274021729
    Version / Model
    LIPC1-3
    Company Name
    DREW SCIENTIFIC, INC.
    Labeler DUNS
    144968104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    d695b732-ba15-4696-8746-1dfb21d8c0e1

    Device Description

    HDL/LDL CHOLESTEROL CONTROL (5x 3mL L1, 5x 3mL L2)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    53392 High density lipoprotein (HDL) cholesterol IVD, kit, mass spectrometry

    Identifiers

    Type ID
    Primary 00817274021729

    Customer Contacts

    Phone
    1-305-324-2300
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius