Definition: Sirolimus Test Systems Are Intended For The Quantitative Measurement Of Sirolimus In Whole Blood As An Aid In Management Of Transplant Patients Taking This Sirolimus.
| Device Type ID | 6244 |
| Device Name | Sirolimus Test System |
| 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 | NRP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6244 |
| Device | Sirolimus Test System |
| Product Code | NRP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sirolimus Test System. |
| CFR Regulation Number | 862.3840 [🔎] |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 7 |
High Test Results | 5 |
Low Test Results | 3 |
| Total Device Problems | 15 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-10-2016 |