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    FDA UDI In Commercial Distribution 🇺🇸 United States

    STELLUX® Chemi Human Total Proinsulin ELISA

    DI: B24280PINHUTCH010 · Model: 80-PINHUT-CH01 · AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STELLUX® Chemi Human Total Proinsulin ELISA
    Primary DI
    B24280PINHUTCH010
    Version / Model
    80-PINHUT-CH01
    Catalog Number
    80-PINHUT-CH01
    Company Name
    AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
    Labeler DUNS
    784143778
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-17
    Public Version
    1
    Public Version Date
    2020-07-27
    Public Version Status
    New
    Public Device Record Key
    8196bdcd-56b7-4a79-9cbf-ab5e95f5cd20

    Device Description

    The Proinsulin (Total) Chemiluminescence ELISA is designed for the quantitative determination of proinsulin in human serum, plasma (EDTA and heparin), and tissue culture supernatants. For in vitro diagnostic use.

    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
    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
    JKD Radioimmunoassay, C-Peptides Of Proinsulin

    GMDN Terms

    Code Name
    54330 Proinsulin IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B24280PINHUTCH010

    Customer Contacts

    Phone
    800.592.5726
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius