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510(k) Data Aggregation
K Number
K232543Device Name
MSC SFM
Manufacturer
Yocon Biology Technology Company
Date Cleared
2024-09-06
(381 days)
Product Code
NDS
Regulation Number
876.5885Why did this record match?
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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
K240247Device Name
MoFi Cell Culture Basal Medium
Manufacturer
DuoGenic StemCells Corporation
Date Cleared
2024-07-12
(164 days)
Product Code
NDS
Regulation Number
876.5885Why did this record match?
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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
K231804Device Name
PRIME-XV FreezIS DMSO-Free MD
Manufacturer
Fujifilm Irvine Scientific
Date Cleared
2023-11-09
(142 days)
Product Code
NDS
Regulation Number
876.5885Why did this record match?
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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
K201789Device Name
CT-STOR
Manufacturer
Energy Delivery Solutions
Date Cleared
2021-09-20
(447 days)
Product Code
NDS
Regulation Number
876.5885Why did this record match?
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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
K113566Device 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
876.5885Why did this record match?
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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
K103302Device Name
STEMPRO MSC SFM
Manufacturer
LIFE TECHNOLOGIES CORPORATION
Date Cleared
2011-02-18
(101 days)
Product Code
NDS
Regulation Number
876.5885Why did this record match?
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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
K100616Device 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
876.5885Why did this record match?
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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
K022086Device Name
AIM-V (R) MEDIUM, MODEL 087-0112
Manufacturer
INVITROGEN CORPORATION
Date Cleared
2002-12-23
(179 days)
Product Code
NDS
Regulation Number
876.5885Why did this record match?
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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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