BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ALT / BS200

    DI: 00817439020178 · Model: ALT600 · Medtest Dx, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ALT / BS200
    Primary DI
    00817439020178
    Version / Model
    ALT600
    Catalog Number
    ALT600
    Company Name
    Medtest Dx, Inc.
    Labeler DUNS
    070371210
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-27
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    17a52713-5194-4e95-af22-d1910e91f726

    Device Description

    For the quantitative determination of Alanine Aminotransferase (ALT) in serum using the Mindray BS-200 analyzer. 2 x 40 ml, 2 x 10 ml

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

    GMDN Terms

    Code Name
    52923 Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

    Identifiers

    Type ID
    Primary 00817439020178

    Customer Contacts

    Phone
    800-445-9853
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius