CEDIA SIROLIMUS ASSAY
Device Facts
| Record ID | DEN040008 |
|---|---|
| Device Name | CEDIA SIROLIMUS ASSAY |
| Applicant | Microgenics Corp. |
| Product Code | NRP · Clinical Toxicology |
| Decision Date | Jul 28, 2004 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 862.3840 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.
