Cardiac Allograft Gene Expression Profiling Test System
FDA product code OJQ · Class II (moderate risk) · 21 CFR 862.1163 · Cardiovascular
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.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221640 | AlloMap Heart Molecular Expression TestingOJQ · Traditional | Caredx, Inc. | 09/13/2023SE |