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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tinaquant Apolipoprotein AI ver2

    DI: 04015630930227 · Model: 6301703190 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tinaquant Apolipoprotein AI ver2
    Primary DI
    04015630930227
    Version / Model
    6301703190
    Catalog Number
    6301703190
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    0f2445dc-db55-496a-b6b5-d334428e91a5

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DER ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    53443 Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 04015630930227

    Premarket Submissions

    Submission Number Supplement Number
    K013249 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius