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    FDA UDI In Commercial Distribution 🇺🇸 United States

    MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100

    DI: 03661540952173 · Model: 800332-100 · ELITECH GROUP INC.
    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® BKV Primer Mix ASR - 480 Reactions QTY 100
    Primary DI
    03661540952173
    Version / Model
    800332-100
    Catalog Number
    800332-100
    Company Name
    ELITECH GROUP INC.
    Labeler DUNS
    079696864
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-04
    Public Version
    1
    Public Version Date
    2022-04-12
    Public Version Status
    New
    Public Device Record Key
    fa8cc3c7-4c72-448f-a170-c560d630765b

    Device Description

    MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from BK Virus. The mix consists of a total of 2.6 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 72 nucleic acid sequence from the VP1 region of BK Virus. QTY 100; 480 reactions each.

    Device Characteristics

    Single Use
    Yes
    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
    49849 BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 03661540952173

    Customer Contacts

    Phone
    8004532725
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – -10 Degrees Celsius