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510(k) Data Aggregation

    K Number
    K232543
    Device Name
    MSC SFM
    Manufacturer
    Yocon Biology Technology Company
    Date Cleared
    2024-09-06

    (381 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MSC SFM is a liquid tissue culture medium product intended for human ex-vivo tissue and cell culture processing applications.
    Device Description
    MSC SFM is a serum-free medium specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). MSC SFM contains MSC SFM Basal Medium and MSC SFM supplement, MSC SFM supplement is a growth factor that should be added to the MSC SFM Basal Medium when use. Using MSC SFM, human MSCs can be expanded for multiple passages while maintaining their trilineage mesoderm potential (i.e., ability to differentiate into osteogenic and adipogenic lineages). Each container is aseptically filled.
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    K Number
    K240247
    Device Name
    “MoFi” Cell Culture Basal Medium
    Manufacturer
    DuoGenic StemCells Corporation
    Date Cleared
    2024-07-12

    (164 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MoFi is a liquid culture medium intended for human ex vivo tissue and cell culture processing applications.
    Device Description
    MoFi is a basal medium based on Iscove's Modified Dulbecco's Medium (IMDM) and cell-degradabe polysaccharide, made of water, carbohydrate, amino acid and salt. It can be mixed with various serums or additional additives to form a complete medium, which can be used to culture suspension/adherent primary cultured cells or cell lines. MoFi provides cells with energy to maintain survival and promote growth.
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    K Number
    K231804
    Device Name
    PRIME-XV FreezIS DMSO-Free MD
    Manufacturer
    Fujifilm Irvine Scientific
    Date Cleared
    2023-11-09

    (142 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PRIME-XV FreezIS DMSO-Free MD is for use in human ex vivo tissue and cell culture processing applications.
    Device Description
    PRIME-XV Freez/S DMSO-Free MD is a liquid medium intended for use in human ex vivo tissue and cell culture processing applications. It is a chemically defined cryogenic preservation solution for human cells for use in a professional Healthcare Facility that performs cell culture and cell handling. It has comparable post-thaw cell viability as solutions containing dimethyl sulfoxide (DMSO), maintains potency of stem cells throughout cryopreservation, eliminates the risk of DMSO in stem cell therapy applications, is animal componentfree, enables cell preservation at -80°C to -196°C environments and is manufactured under cGMP conditions.
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    K Number
    K201789
    Device Name
    CT-STOR
    Manufacturer
    Energy Delivery Solutions
    Date Cleared
    2021-09-20

    (447 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CT-STOR is a liquid culture media intended for ex vivo cell and tissue processing applications
    Device Description
    CT-STOR is a tissue culture media intended for human ex vivo tissue and cell culture processing applications. AIM-V® is the predicate device and is also a tissue culture media intended for human ex vivo tissue and cell culture processing applications. CT-STOR and AIM-V® are composed of chemically defined nutrient materials in solution (with or without supplements) that are essential for the survival and development of tissue or cells of human or other animal origin. These nutrients are provided in liquid form for use in supporting the growth or maintenance of human tissue and cells.
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    K Number
    K113566
    Device Name
    OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
    Manufacturer
    LIFE TECHNOLOGIES, INC.
    Date Cleared
    2012-06-21

    (202 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OpTmizer™ CTS™ T-Cell Expansion SFM is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.
    Device Description
    OpTmizer™ CTS™ T-Cell Expansion SFM has been developed for the growth and expansion of human T lymphocytes. OpTmizer™ CTS™ T-Cell Expansion SFM is a complete serum-free and xeno-free 1X medium consisting of the OpTmizer™ T-Cell Expansion Basal Medium with the addition of the OpTmizer™ T-Cell Expansion Supplement. OpTmizer™ CTS™ T-Cell Expansion Medium is designed for the expansion of CD3+ densities of > 3 x 10° cells/mL in static conditions and > 2 x 10′ cells/ML in Wave bags.
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    K Number
    K103302
    Device Name
    STEMPRO MSC SFM
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Date Cleared
    2011-02-18

    (101 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StemPro® MSC SFM Medium is a liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.
    Device Description
    StemPro® MSC SFM is a serum-free medium (SFM) specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). StemPro® MSC SFM enables human MSC growth and increased consistency compared to classical serum-supplemented medium. In addition, human MSCs can be expanded for multiple passages while maintaining their multipotential phenotype (i.e. ability to differentiate into osteogenic, chondrogenic, adipogenic lineages). StemPro® MSC SFM contains two components: StemPro® MSC SFM Basal Medium and StemPro® MSC SFM Supplement.
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    K Number
    K100616
    Device Name
    KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Date Cleared
    2010-05-20

    (77 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Knockout™ SR Medium and Knockout™ SR Xenofree Medium are liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.
    Device Description
    Knockout™ SR is a serum-free medium with a defined formulation that provides consistent growth conditions for human and mouse embryonic stem cell (ESC) and patient-specific induced pluripotent cell lines (iPSCs). Knockout™ SR Xenofree is a serum-free and animal origin-free defined formulation that provides consistent growth conditions for human and mouse embryonic stem cell (ESC) and patient-specific induced pluripotent cell lines (iPSCs). All animal derived components have been replaced with human derived or synthetic components to yield a xenogeneic-free formulation.
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    K Number
    K022086
    Device Name
    AIM-V (R) MEDIUM, MODEL 087-0112
    Manufacturer
    INVITROGEN CORPORATION
    Date Cleared
    2002-12-23

    (179 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.
    Device Description
    AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications. AIM-V® is a serum-free medium developed in 1987 to support adoptive immunotherapy (lymphokine-activated killer (LAK) cells) clinical trials. The formula for AIM-V® has remained the same since it was first manufactured with only slight quantity variations. AIM-V® Medium is prepared from a master formulation of Dulbecco's Modified Eagle Medium, HEPES buffer, human serum albumin.USP, human transferrin, and cholesterol, NF(which help promote growth of the cells and tissue).
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    K Number
    DEN000008
    Device Name
    DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
    Manufacturer
    LIFE TECHNOLOGIES, INC.
    Date Cleared
    2001-02-16

    (59 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Why did this record match?
    Product Code :

    NDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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