Prognostic Test For Assessment Of Chronic Kidney Disease Progression

QWZ · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1223

Classification

FDA Product Code: QWZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1223
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

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