BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MGB Alert Enterovirus v.2.0 Probe Mix ASR , 48 rxns

    DI: 03661540952111 · Model: M800709 · Elitechgroup Mdx LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    MGB Alert Enterovirus v.2.0 Probe Mix ASR , 48 rxns
    Primary DI
    03661540952111
    Version / Model
    M800709
    Catalog Number
    M800709
    Company Name
    Elitechgroup Mdx LLC
    Labeler DUNS
    117458512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-21
    Public Version
    2
    Public Version Date
    2023-10-30
    Public Version Status
    Update
    Public Device Record Key
    b76f9a14-3ddc-4df3-9045-1da669cbbf5d

    Device Description

    DSQ Alert Enterovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 0.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MVU Reagents, Specific, Analyte

    GMDN Terms

    Code Name
    48692 Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 03661540952111

    Customer Contacts

    Phone
    8004532725
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – -10 Degrees Celsius