BEUDAMED
    FDA Registration Active 🇨🇳 China

    Influenza A/B Antigen Rapid Test, Proven Medical Testing LLC, Over the counter, OTC;

    Reg #: 3016630443 · FEI: 3016630443 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    6
    Classifications
    1

    Registration Details

    Registration Name
    Eugene Biotech Co., Ltd.
    Registration Number
    3016630443
    FEI Number
    3016630443
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Build 1, Runcai Intelligent Industrial Park, No.1666 XinYang Road, Fengxian District
    City
    Shanghai
    Country
    CN

    Owner / Operator

    Firm Name
    BioMediCore Inc.
    Operator Number
    10064231
    Address
    352 Forest View Dr
    City
    South San Francisco
    State
    CA
    Postal Code
    94080
    Country
    US

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Antigens, Cf (Including Cf Control), Influenza Virus A, B, C GNX

    Proprietary Names

    Influenza A/B Antigen Rapid Test, Proven Medical Testing LLC, Over the counter, OTC; Influenza type A and B (Flu A/B) Ag, Over the counter, OTC

    Establishment Types

    Remanufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device