OJQ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cardiac Allograft Gene Expression Profiling Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1163
- Medical specialty
- Cardiovascular
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| AlloMap Heart Molecular Expression Testing (K221640) | Caredx, Inc. | 2023-09-13 |
| ALLOMAP MOLECULAR EXPRESSION TESTING (DEN080007) | Xdx | 2008-08-26 |
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