BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MGB Alert® 2X Hot Start Master Mix

    Reg #: 3003540236 · FEI: 3003540236 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELITechGroup MDX LLC.
    Registration Number
    3003540236
    FEI Number
    3003540236
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    21720 23rd Dr SE, Suite 150
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US

    Owner / Operator

    Firm Name
    ELITechGroup Inc.
    Operator Number
    1717966
    Address
    370 West 1700 South
    City
    Logan
    State
    UT
    Postal Code
    84321
    Country
    US
    Correspondent
    Roberto Ortiz

    Products

    Device Name Product Code
    General Purpose Reagent PPM

    Proprietary Names

    MGB Alert® 2X Hot Start Master Mix MGB Alert® PCR Master Mix MGB Alert® Positive Controls MGB Alert® Platinum Master Mix MGB Alert One-Step Reverse Transcriptase PCR Master Mix MGB Alert 2X PCR Master Mix (MGB Alert 2X Hot Start Master Mix/Tfi) System Solution System Cleaning Solution Acid Solution SYSTEM SOLUTION For Viva Drug Testing Systems MGB Alert ELITaq Master Mix 48-rxn - M800809 MGB Alert ELITaq Master Mix 480-rxn - M800810 Envoy Rinse Solution Bulk Kit Envoy 500 Wash Solution Kit Envoy Rinse Solution Envoy ISE Conditioner Envoy Rinse Solution Kit

    Establishment Types

    Manufacture Medical Device