BEUDAMED
    FDA Registration Active 🇺🇸 United States

    H. pylori Rapid Test – Whole Blood/Serum (Cassette)

    Reg #: 2060833 · FEI: 3001452245 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ALFA SCIENTIFIC DESIGNS, INC.
    Registration Number
    2060833
    FEI Number
    3001452245
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13200 GREGG ST.
    City
    POWAY
    State
    CA
    ZIP
    92064
    Country
    US

    Regulatory Submissions

    510(k) Number
    K024360

    Owner / Operator

    Firm Name
    ALFA SCIENTIFIC DESIGNS, INC.
    Operator Number
    9034872
    Address
    13200 GREGG ST., --
    City
    Poway
    State
    CA
    Postal Code
    92064
    Country
    US

    Products

    Device Name Product Code
    Helicobacter Pylori LYR

    Proprietary Names

    H. pylori Rapid Test – Whole Blood/Serum (Cassette) Instant-View H. pylori Rapid Test - Serum (Cassette/Dip Strip) Instant-View H. pylori Rapid Test – Whole Blood/Serum (Cassette) H. pylori Rapid Test - Serum (Cassette/Dip Strip)

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)