← Product Code [MGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MGS) · P880032

# BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032)

_Bio-Rad · MGS · Jul 24, 1989 · Clinical Chemistry · APRL_

**Canonical URL:** https://fda.innolitics.com/submissions/CLINICAL%20CHEMISTRY/subpart-b%E2%80%94clinical-chemistry-test-systems/MGS/P880032

## Device Facts

- **Applicant:** Bio-Rad
- **Product Code:** [MGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MGS.md)
- **Decision Date:** Jul 24, 1989
- **Decision:** APRL
- **Regulation:** 21 CFR 862.1235
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.

## Special Controls

*Classification.* Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.

---

**Source:** [https://fda.innolitics.com/submissions/CLINICAL%20CHEMISTRY/subpart-b%E2%80%94clinical-chemistry-test-systems/MGS/P880032](https://fda.innolitics.com/submissions/CLINICAL%20CHEMISTRY/subpart-b%E2%80%94clinical-chemistry-test-systems/MGS/P880032)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com