EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
Device Facts
| Record ID | P920031 |
|---|---|
| Device Name | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
| Applicant | Dade Behring, Inc. |
| Product Code | MKW · Clinical Chemistry |
| Decision Date | Oct 2, 1996 |
| Decision | APRL |
| Regulation | 21 CFR 862.1235 |
| Device Class | Class 2 |
Regulatory Classification
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.
