Definition: To Quantify Everolimus In Whole Blood.
| Device Type ID | 6254 |
| Device Name | Everolimus Immunoassay |
| Physical State | NA |
| Technical Method | Immunoassay |
| Target Area | IVD |
| Regulation Description | Sirolimus Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3840 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6254 |
| Device | Everolimus Immunoassay |
| Product Code | OUF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sirolimus Test System. |
| CFR Regulation Number | 862.3840 [🔎] |
| Device Problems | |
|---|---|
Device Handling Problem | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Microgenics Corporation | II | Oct-03-2016 |