BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Chang Amnio; Chang Marrow (with gentamicin); Chang Medium B; Chang Medium BMC

    Reg #: 3036495174 · FEI: 3036495174 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IRVINE SCIENTIFIC LLC
    Registration Number
    3036495174
    FEI Number
    3036495174
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1830 E Warner Ave
    City
    Santa Ana
    State
    CA
    ZIP
    92705
    Country
    US

    Owner / Operator

    Firm Name
    IRVINE SCIENTIFIC LLC
    Operator Number
    10092955
    Address
    1830 E Warner Ave
    City
    Santa Ana
    State
    CA
    Postal Code
    92705
    Country
    US
    Correspondent
    Ashley M Werner

    Products

    Device Name Product Code
    Kit, Culture, Chromosome KIQ

    Proprietary Names

    Chang Amnio; Chang Marrow (with gentamicin); Chang Medium B; Chang Medium BMC Chang Medium D; Chang Medium D (with gentamicin); Chang Medium In Situ; Chang Medium MF; Colcemid Solution Chang Medium C; Chang Medium C Kit (Lyophilized with Gentamicin); Chang Medium C Kit (lyophilized)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility