BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C

    Reg #: 3011393376 · FEI: 3011393376 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    46
    Establishment Types
    1
    Classifications
    4

    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
    K131029

    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
    Calculator, Drug Dose NDC
    System, Test, Blood Glucose, Over The Counter NBW
    Pump, Infusion, Insulin LZG
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS ACCU-CHEK Aviva Control Solutions ACCU-CHEK AVIVA SMPL KIT BRK 16/CS ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS ACCU-CHEK AVIVA PLUS 10CT STRIP BRK ACCU-CHEK AVIVA RETAIL KIT BRK 8/CS ACCU-CHEK Aviva Meter ACCU-CHEK Aviva Plus Blood Glucose Monitoring System ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C ACCU-CHEK AVIVA PLUS METER ONLY BRK ACCU-CHEK Aviva Combo System ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C ACCU-CHEK AVIVA HNP KIT BRK 8/CS ACCU-CHEK Aviva Plus Test Strip ACCU-CHEK AVIVA STRIPS EURO 100 BRK ACCU-CHEK AVIVA STRIPS UK 50 BRK ACCU-CHEK AVIVA STRIPS SPAIN 50 BRK ACCU-CHEK PERFORMA 50CT STRIP EURO3 ACCU-CHEK INFORM II NORDIC 50CT 10/CS F2 ACCU-CHEK PERFORMA 50 STRIP AGENCIES BRK ACCU-CHEK INFORM II 50CT C EURO F2 10/CS ACCU-CHEK INFORM II NON-EU LA STRIP ACCU-CHEK AVIVA STRIPS GERMANY 50 BRK ACCU-CHEK AVIVA STRIPS SPAIN 10 BRK LABELED VIAL A/C PERFORMA 10CT STRIP ACCU-CHEK PERFORMA 50CT STRIP EURO5 ACCU-CHEK PERFORMA 100CT STRIP EURO1 ACCU-CHEK AVIVA STRIPS GERMANY 10 BRK ACCU-CHEK AVIVA STRIPS EURO 50 BRK ACCU-CHEK PERFORMA 50CT STRIP EURO1 ACCU-CHEK AVIVA STRIPS GR SI PT 50 BRK ACCU-CHEK INFORM II US 50CT 36/CS F2 ACCU-CHEK INFORM II 50 CT UK F2 ACCU-CHEK INFORM II EU2 ACCU-CHEK PERFORMA 10CT STRIP EURO5 ACCU-CHEK AVIVA STRIPS NORDIC 50 BRK ACCU-CHEK PERFORMA 25CT STRIP EURO2 ACCU-CHEK PERFORMA 50CT STRIP TK BRK ACCU-CHEK PERFORMA 50CT STRIPS EURO 6 ACCU-CHEK INFORM II-DE 50CT 10/CS F2 ACCU-CHEK AVIVA STRIPS EURO 25 BRK ACCU-CHEK AVIVA STRIPS SPAIN 100 BRK ACCU-CHEK AVIVA ASPAC STRIP 50CT ACCU-CHEK PERFORMA 50CT STRIP NON EU ACCU-CHEK INFORM II EU1

    Establishment Types

    Manufacture Medical Device