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Cardiac Allograft Gene Expression Profiling Test System

FDA product code OJQ · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 862.1163
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-09-13 – 2023-09-13

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.

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