BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    JAS Diagnostics

    DI: 00817274022221 · Model: TA103577 · 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
    00817274022221
    Version / Model
    TA103577
    Company Name
    DREW SCIENTIFIC, INC.
    Labeler DUNS
    144968104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-12
    Public Version
    4
    Public Version Date
    2023-08-03
    Public Version Status
    Update
    Public Device Record Key
    fa3754e9-288e-4b0c-a424-8216ebaff39b

    Device Description

    XL-400 Clinical Chemistry Analyzer

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    GMDN Terms

    Code Name
    56724 Multichannel immunoassay analyser IVD

    Identifiers

    Type ID
    Primary 00817274022221

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    18 – 30 Degrees Celsius