BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NOVEOS Probe Wash

    Reg #: 2016473 · FEI: 1000125787 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HYCOR BIOMEDICAL
    Registration Number
    2016473
    FEI Number
    1000125787
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7272 Chapman Ave
    City
    GARDEN GROVE
    State
    CA
    ZIP
    92841
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242531

    Owner / Operator

    Firm Name
    Hycor Biomedical
    Operator Number
    2016473
    Address
    7272 Chapman Avenue
    City
    Garden Grove
    State
    CA
    Postal Code
    92841
    Country
    US
    Correspondent
    Aashrey Kaul

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    System, Test, Radioallergosorbent (Rast) Immunological DHB

    Proprietary Names

    NOVEOS Probe Wash NOVEOS Capture Reagent G002, Bermuda Grass (Cynodon dactylon); NOVEOS Fluo Beads NOVEOS IgE Positive Control NOVEOS Capture Reagent T007, Oak (Quercus alba); NOVEOS Capture Reagent T003, Common Silver Birch (Betula verrucosa); NOVEOS Immunoassay Analyzer NOVEOS IgE Negative Control NOVEOS IgE Calibrator Antibody NOVEOS Capture Reagent F001, Egg White (Gallus gallus); NOVEOS Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); NOVEOS Diluent A NOVEOS Cuvette Wash NOVEOS Capture Reagent G010, Johnson Grass (Sorghum halepense); NOVEOS Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Capture Reagent E005, Dog Dander (Canis familiaris); NOVEOS Wash Buffer Concentrate NOVEOS Substrate Pack (Substrate A and Substrate B) NOVEOS Conjugate IgE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device