Sirolimus Test System

NRP · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3840

Classification

FDA Product Code: NRP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3840
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown