BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QuantiFluor® Dx dsDNA System

    DI: 00849811075902 · Model: E5900 · PROMEGA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QuantiFluor® Dx dsDNA System
    Primary DI
    00849811075902
    Version / Model
    E5900
    Catalog Number
    E5900
    Company Name
    PROMEGA CORPORATION
    Labeler DUNS
    089855696
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-15
    Public Version
    1
    Public Version Date
    2023-08-23
    Public Version Status
    New
    Public Device Record Key
    c956f46c-6d1a-42db-9ed0-ba63cd2a5000

    Device Description

    The QuantiFluor® Dx dsDNA System is a fluorescent dye-based test intended to quantify double-stranded DNA (dsDNA) in a sample containing purified nucleic acid.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    PEG Nucleic Acid Quantitation Kit

    GMDN Terms

    Code Name
    52521 Nucleic acid extraction/isolation kit IVD

    Identifiers

    Type ID
    Primary 00849811075902

    Customer Contacts

    Phone
    608-839-7919
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius