BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MGB Alert HHV-6 Primer Mix ASR - 480 rxn

    DI: 03661540951336 · Model: 800338 · Elitechgroup Mdx LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MGB Alert HHV-6 Primer Mix ASR - 480 rxn
    Primary DI
    03661540951336
    Version / Model
    800338
    Catalog Number
    800338
    Company Name
    Elitechgroup Mdx LLC
    Labeler DUNS
    117458512
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-14
    Public Version
    3
    Public Version Date
    2025-12-23
    Public Version Status
    Update
    Public Device Record Key
    0e1b9801-bec2-47b0-99fa-b0da3b02f8c0
    Distribution End Date
    2025-12-22

    Device Description

    "MGB Alert® HHV-6 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HHV-6 (Human Herpesvirus 6). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 115 nucleic acid sequence from the U67 gene region of HHV-6. "

    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
    49743 Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 03661540951336

    Customer Contacts

    Phone
    8005452725
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – -10 Degrees Celsius