CRP High Sensitivity

Primary DI

16438153817984

Basic UDI-DI Code

6438153BU00060BK

Reference

981798

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

For in vitro diagnostic use in the quantitative determination of low concentrations of C-reactive protein (CRP) in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The CRP High Sensitivity test is indicated to be used in conjunction with clinical evaluation as an aid for prediction and monitoring the risk of cardiovascular diseases and disorders, such as myocardial infarction, stroke, peripheral vascular disease and sudden cardiac death, in patients. Additionally, the CRP High Sensitivity test is also used in conjunction with clinical evaluation as an aid in the prediction of the risk for future metabolic syndrome, diabetes and hypertension, in patients.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).