Product code NRP
- Device name
- Sirolimus Test System
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3840
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset