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    FDA Registration Active 🇹🇷 Türkiye

    Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

    Reg #: 3011989923 · FEI: 3011989923 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI
    Registration Number
    3011989923
    FEI Number
    3011989923
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oruc Reis Mahallesi, Giyimkent 3 Sokak No 21A-23A Esenler
    City
    Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K153651

    Owner / Operator

    Firm Name
    Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti
    Operator Number
    10060275
    Address
    Oruc Reis Mahallesi, Giyimkent 3 Sokak No 21A-23A Esenler
    City
    Istanbul
    State
    TR-34
    Postal Code
    34235
    Country
    TR

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Calibrator, Primary JIS
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW

    Proprietary Names

    Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device