BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    Premier Resolution Analyzer

    Reg #: 3032069621 · FEI: 3032069621 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Trinity Biotech do Brasil
    Registration Number
    3032069621
    FEI Number
    3032069621
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Estrada Vereador Lamartine Jose de Oliveira, 1259-A
    City
    Extrema Minas Gerais
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K222635

    Owner / Operator

    Firm Name
    TRINITY BIOTECH, PLC
    Operator Number
    9025161
    Address
    2823 Girts Rd
    City
    Jamestown
    State
    NY
    Postal Code
    14701
    Country
    US

    Products

    Device Name Product Code
    Abnormal Hemoglobin Quantitation GKA

    Proprietary Names

    Premier Resolution Analyzer Premier Resolution Assay Components

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)