Cardiac Allograft Gene Expression Profiling Test System
OJQ is the FDA product code for Cardiac Allograft Gene Expression Profiling Test System, a class II device type, regulated under 21 CFR 862.1163. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OJQ
- Device name
- Cardiac Allograft Gene Expression Profiling Test System
- 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.
- Regulation
- 21 CFR 862.1163
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code OJQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code OJQCompanies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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