BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accu-Sed® Plus Normal / Abnormal ESR Control, 2x8.5mL

    Reg #: 1717966 · FEI: 1717966 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ELITechGroup Inc
    Registration Number
    1717966
    FEI Number
    1717966
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    370 West 1700 South
    City
    LOGAN
    State
    UT
    ZIP
    84321
    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

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Accu-Sed® Plus Normal / Abnormal ESR Control, 2x8.5mL Accu-Sed® Plus Normal / Abnormal ESR Control Set, 10x8.5mL Sweat Controls, L1, L2, L3, 12 ea., 36x0.75mL Accu-Sed® Plus Normal ESR Control, 5x8.5mL Accu-Sed® Plus Abnormal ESR Control, 5x8.5mL Accu-Sed® Plus Normal / Abnormal ESR Control, 4x8.5 mL M800752 - MGB Alert CMV Positive Control DNA Template M800751 - MGB Alert Adenovirus Positive Control DNA Template M800749 - MGB Alert HHV-6 Positive Control DNA Template M800748 - MGB Alert® EBV Positive Control DNA Template M800750 - MGB Alert BK Virus Positive Control DNA Template

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device