BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Acrometrix Multi-Analyte Control HIV/HCV/HBV High

    Reg #: 3010939897 · FEI: 3010939897 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Microgenics Corporation
    Registration Number
    3010939897
    FEI Number
    3010939897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    46500 Kato Road
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Multi-Analyte Controls Unassayed OHQ

    Proprietary Names

    Acrometrix Multi-Analyte Control HIV/HCV/HBV High Acrometrix CT/NG Control Acrometrix Multi-Analyte Control HIV/HCV/HBV Low Acrometrix Oncology Hotspot Control Acrometrix Triscreen MAS Omni Infectious BSI Positive Control Panel MAS Infectious Negative Control MAS anti-HBs Positive Control MAS Syphilis Positive Control MAS anti-HBs Positive Control for use with Siemens Assays MAS HIV p24 Positive Control MAS Omni Infectious BSI Positive Control Panel for Use with Siemens Assays

    Establishment Types

    Manufacture Medical Device