Pure Global

Prognostic Test For Assessment Of Chronic Kidney Disease Progression

Prognostic Test For Assessment Of Chronic Kidney Disease Progression is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Prognostic Test For Assessment Of Chronic Kidney Disease Progression
Clinical Chemistry Medical Device Type
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Regulatory Classifications

US Regulatory Classifications

QWZ

View Product Code Classification

Class 2

21 CFR 862.1223

View CFR Regulation

Clinical Chemistry

Device Characteristics

No

No

No

Not Eligible

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.