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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Augurex Life Sciences

    DI: 06284510990394 · Model: 90-0038 · Cedarlane Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Augurex Life Sciences
    Primary DI
    06284510990394
    Version / Model
    90-0038
    Catalog Number
    90-0038
    Company Name
    Cedarlane Corporation
    Labeler DUNS
    243928822
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    1
    Public Version Date
    2022-12-16
    Public Version Status
    New
    Public Device Record Key
    765bcb39-efa1-4ed3-a3dc-f4c30a010573

    Device Description

    14-3-3eta Rec. Human, Lyophilized ASR

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MVU Reagents, Specific, Analyte

    GMDN Terms

    Code Name
    53964 Protein 14-3-3 IVD, calibrator

    Identifiers

    Type ID
    Primary 06284510990394

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 1 Bag (contains 10 vials)

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius