Cardiac Allograft Gene Expression Profiling Test System
Device Code: 687
Product Code(s):
OJQ 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 Identif
Device Classification Information
| Device Type ID | 687 |
| Device Name | Cardiac Allograft Gene Expression Profiling Test System |
| Physical State | Laboratory Based Test |
| Technical Method | Quantitative Real-time Polymerase Chain Reaction Technology (qRT-PCR) |
| Target Area | Cardiac Allograft |
| Regulation Description | Cardiac Allograft Gene Expression Profiling Test System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1163 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OJQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 687 |
| Device | Cardiac Allograft Gene Expression Profiling Test System |
| Product Code | OJQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiac Allograft Gene Expression Profiling Test System. |
| CFR Regulation Number | 862.1163 [🔎] |
TPLC Last Update: 2019-04-02 19:38:42