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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cardiac allograft gene expression profiling test system
Regulation Description Cardiac allograft gene expression profiling test system.
Definition In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment.
Product CodeOJQ
Regulation Number 862.1163
Device Class 2

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