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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
DuoGenic StemCells Corporation
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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