BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCU-CHEK AVIVA PLUS SAMPLE KIT 16/CASE

    Reg #: 3011393376 · FEI: 3011393376 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ROCHE DIABETES CARE, INC.
    Registration Number
    3011393376
    FEI Number
    3011393376
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    ZIP
    46250
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133862

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US
    Correspondent
    Brian Frazier

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    ACCU-CHEK AVIVA PLUS SAMPLE KIT 16/CASE ACCU-CHEK AVIVA PLUS Retail KIT 8/CASE ACCU-CHEK Aviva Plus Test Strip ACCU-CHEK Aviva Meter ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE ACCU-CHEK AVIVA PLUS SYSTEM ACCU-CHEK Aviva Plus Blood Glucose Monitoring System ACCU-CHEK AVIVA PLUS METER-ONLY ACCU-CHEK Aviva Control Solutions ACCU-CHEK AVIVA PLUS 25CT STRIP 36/CS ACCU-CHEK AVIVA PLUS Retail KIT 10/CASE ACCU-CHEK AVIVA PLUS SAMPLE KIT 20/CASE ACCU-CHEK AVIVA PLUS METER ONLY US

    Establishment Types

    Manufacture Medical Device