BEUDAMED
    FDA Registration Active 🇫🇷 France

    HbA1c Calibrator Set, 4 x 0.5 mL, REF HBAC-0043-NA

    Reg #: 3007662974 · FEI: 3007662974 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    VitalScientific
    Registration Number
    3007662974
    FEI Number
    3007662974
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zone Industrielle, 13 rue Auguste Mottin
    City
    SEES Normandie
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K100547

    Owner / Operator

    Firm Name
    VitalScientific
    Operator Number
    10090892
    Address
    13 Rue Auguste Mottin - Zone Industrielle
    City
    SEES
    State
    Orne
    Postal Code
    61500
    Country
    FR
    Correspondent
    Valerie LAMBERT

    US Agent

    Business Name
    Clinical Diagnostic Solutions, Inc
    Contact Name
    Junelle Goldson
    Address
    1800 Nw 65th Ave
    City
    Plantation
    State
    FL
    ZIP
    33313
    Country
    US
    Email
    [email protected]
    Phone
    954 7911773

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Assay, Glycosylated Hemoglobin LCP
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    HbA1c Calibrator Set, 4 x 0.5 mL, REF HBAC-0043-NA HbA1c, 1 x 32 mL, REF HBAC-0240-NA HbA1c Control L + H, 4 x 0.5 mL, REF HBAC-0049-NA

    Establishment Types

    Manufacture Medical Device