BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Respiratory virus panel nucleic acid assay system

    Reg #: 3003018722 · FEI: 3003018722 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ENERCON TECHNOLOGIES
    Registration Number
    3003018722
    FEI Number
    3003018722
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25 NORTHBROOK DR., P.O. BOX 665
    City
    GRAY
    State
    ME
    ZIP
    04039
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151690

    Owner / Operator

    Firm Name
    ENERCON TECHNOLOGIES
    Operator Number
    9051058
    Address
    25 NORTHBROOK DR., P.O. BOX 665
    City
    Gray
    State
    ME
    Postal Code
    04039
    Country
    US

    Products

    Device Name Product Code
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    Respiratory virus panel nucleic acid assay system Influenza A and influenza B multiplex nucleic acid assay Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system real time Nucleic acid amplification system

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)