NRP

Sirolimus Test System

Product code: NRP
Device name: Sirolimus Test System
Device class: Class 2
21 CFR: 21 CFR 862.3840
Medical specialty: Clinical Toxicology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

FDA classification definition

Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NRP

Classification and pathway per current FDA publications. Data from openFDA (CC0).