BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUJIFILM Biosciences INC.

    Reg #: 2022379 · FEI: 2022379 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    FUJIFILM Biosciences INC.
    Registration Number
    2022379
    FEI Number
    2022379
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2511 DAIMLER ST
    City
    Santa Ana
    State
    CA
    ZIP
    92705
    Country
    US

    Owner / Operator

    Firm Name
    FUJIFILM Holdings America Corporation
    Operator Number
    2022379
    Address
    2511 DAIMLER STREET, --
    City
    Santa Ana
    State
    CA
    Postal Code
    92705
    Country
    US
    Correspondent
    Marlin Frechette

    Products

    Device Name Product Code
    Media, Reproductive MQL
    Labware, Assisted Reproduction MQK
    Kit, Culture, Chromosome KIQ
    Media And Components, Synthetic Cell And Tissue Culture KIT

    Proprietary Names

    Hyaluronidase Solution Continuous Single Culture with Gentamicin Fast Warm NX cryo-GO Human Serum Albumin (HSA) Refrigeration Medium Test Yolk Buffer (TYB) with Gentamicin Freezing Medium Test Yolk Buffer (TYB) with Gentamicin Continuous Single Culture®–NX (CSCM–NX) SSS-NX (Serum Substitute Supplement-NX) ISolate® Stock Solution ISolate® Modified HTF Medium HEPES with Gentamicin HTF Medium with Gentamicin Arctic Sperm Cryopreservation Medium PBS 1X - Dulbecco's Phosphate Buffered Saline Solution Vit Kit - Freeze NX Vit Kit - Warm NX Chang Medium C; Chang Medium C Kit (Lyophilized with Gentamicin); Chang Medium C Kit (lyophilized) 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 Multipurpose Handling Medium Multipurpose Handling Medium Complete Continuous Single Culture Complete Oil for Embryo Culture Heavy Oil for Embryo Culture 10% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA) 7% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA) Continuous Single Culture®–NX Complete (CSCM–NXC) Chang Medium D (with gentamicin) Chang Medium B Chang Medium MF Chang Medium C Kit (lyophilized) Chang Medium BMC Chang Amnio Chang Marrow (with gentamicin) Chang Medium In Situ Chang Medium C Kit (Lyophilized with Gentamicin) Colcemid Solution Chang Medium D Chang Medium C Sperm Washing Medium Vit Kit Vitrification Freeze Kit; Vit Kit Vitrification Thaw Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)