BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Elecsys Folate III CalSet

    Reg #: 9610529 · FEI: 3002806560 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ROCHE DIAGNOSTICS GMBH
    Registration Number
    9610529
    FEI Number
    3002806560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NONNENWALD 2
    City
    PENZBERG Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K082340

    Owner / Operator

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

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Acid, Folic, Radioimmunoassay CGN

    Proprietary Names

    Elecsys Folate III CalSet Elecsys RBC Folate Hemolysing Reagent Elecsys PreciControl Anemia Elecsys Folate III CalCheck Folate G3 CC 3 Elecsys Folate G3 CS Elecsys V2 ELECSYS FOLATE GEN 3 CALCHECK KIT Elecsys Folate III Elecsys Folate gen 3 products

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility