DeviceClearance

Product code OUF— Clinical Toxicology

THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY

Classification name
Everolimus Immunoassay
Device class
Class 2
Regulation
21 CFR 862.3840
Advisory panel
Clinical Toxicology
Total cleared
2
First cleared
Most recent

FDA classification definition

“To quantify everolimus in whole blood.”

— U.S. Food and Drug Administration, device classification record for product code OUF under 21 CFR 862.3840, via openFDA

Market context for product code OUF

FDA has cleared 2 devices under product code OUF between 2011 and 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OUF

Recent clearances under product code OUF

Data sourced from openFDA. This site is unofficial and independent of the FDA.