← Product Code [NRP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP) · DEN040008

# CEDIA SIROLIMUS ASSAY (DEN040008)

_Microgenics Corp. · NRP · Jul 28, 2004 · Clinical Toxicology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP/DEN040008

## Device Facts

- **Applicant:** Microgenics Corp.
- **Product Code:** [NRP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP.md)
- **Decision Date:** Jul 28, 2004
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 862.3840
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP/DEN040008](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/NRP/DEN040008)

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