BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OncoMate 5C Matrix Standard

    DI: 00849811050619 · Model: MD4850 · PROMEGA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OncoMate 5C Matrix Standard
    Primary DI
    00849811050619
    Version / Model
    MD4850
    Catalog Number
    MD4850
    Company Name
    PROMEGA CORPORATION
    Labeler DUNS
    089855696
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-30
    Public Version
    1
    Public Version Date
    2021-10-08
    Public Version Status
    New
    Public Device Record Key
    3bc0f50a-e636-4542-8177-cdc02a8a1b8d

    Device Description

    Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Analyzer to generate a multicomponent matrix that is applied during the subsequent analysis of amplification products from the OncoMate™ MSI Dx Analysis System.

    Device Characteristics

    Single Use
    No
    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
    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
    PZJ Lynch Syndrome Test System

    GMDN Terms

    Code Name
    60204 Microsatellite instability IVD, reagent

    Identifiers

    Type ID
    Primary 00849811050619