OUF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Everolimus Immunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3840
- Medical specialty
- Clinical Toxicology
- FDA definition
- To quantify everolimus in whole blood.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY (K122766) | Microgenics Corp. | 2013-08-20 |
| THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS (K100144) | Microgenics Corp. | 2011-02-11 |
Track OUF automatically
Every clearance here is in the API, with alerts when new ones post.