BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    CRP CALIBRATOR WR

    Reg #: 9681753 · FEI: 3000303338 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SENTINEL CH. SPA
    Registration Number
    9681753
    FEI Number
    3000303338
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA ROBERT KOCH, 2
    City
    MILANO
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K050836

    Owner / Operator

    Firm Name
    SENTINEL CH. SpA
    Operator Number
    9025279
    Address
    Via Robert Koch, 2
    City
    Milan
    State
    Milano
    Postal Code
    20152
    Country
    IT

    US Agent

    Business Name
    Diagnostic Oncology CRO, LLC
    Contact Name
    Robert McNamee
    Address
    1 Jacks Hill Rd Ste 1ab
    City
    Oxford
    State
    CT
    ZIP
    06478
    Country
    US
    Email
    [email protected]
    Phone
    203 5989105

    Products

    Device Name Product Code
    Calibrator, Primary JIS
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    CRP CALIBRATOR WR Alinity c CRP Vario HS Control Kit CRP CONTROL HS CRP CALIBRATOR HS CRP CALIBRATOR SET CRP VARIO

    Establishment Types

    Manufacture Medical Device