BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AST

    DI: 05055273200423 · Model: AS1204 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AST
    Primary DI
    05055273200423
    Version / Model
    AS1204
    Catalog Number
    AS1204
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    ab0d0de2-aef9-49ee-ad1d-215923ea0677

    Device Description

    The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.

    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
    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
    CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

    GMDN Terms

    Code Name
    52953 Aspartate aminotransferase (AST) isoenzyme IVD, reagent

    Identifiers

    Type ID
    Primary 05055273200423

    Customer Contacts

    Phone
    +442894451070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K923505 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Stable for 14 days at +2 to +8°C or 24 hours at +15 to +25°C once reconstituted.