BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PHASE DIAGNOSTICS

    Reg #: 3014022295 · FEI: 3014022295 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    PHASE DIAGNOSTICS
    Registration Number
    3014022295
    FEI Number
    3014022295
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    10527 Garden Grove Blvd.
    City
    Garden Grove
    State
    CA
    ZIP
    92843
    Country
    US

    Owner / Operator

    Firm Name
    PHASE Diagnostics
    Operator Number
    10075679
    Address
    10527 Garden Grove Blvd.
    City
    Garden Grove
    State
    CA
    Postal Code
    92843
    Country
    US
    Correspondent
    Ricky Chiu

    Products

    Device Name Product Code
    Container, Specimen Mailer And Storage, Sterile KDT
    Reagent, Coronavirus Serological QKO
    Urine Collection Kit (Excludes Hiv Testing) OIE
    Coronavirus Antigen Detection Test System. QKP

    Proprietary Names

    INDICAID health Urine Collection Kit INDICAID COVID-19 IgM/IgG Rapid Test INDICAID health Sexual Health 2 Urine Collection INDICAID COVID-19 Rapid Antigen Test

    Establishment Types

    Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198