CRP Plus

Primary DI

16438153819346

Basic UDI-DI Code

6438153BU00106BJ

Reference

981934

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

For in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The CRP Plus test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of infections and systemic inflammatory processes and diseases, such as invasive bacterial infections and extensive tissue damage, in patients. Furthermore, the CRP Plus test is indicated to be used in conjunction with clinical evaluation for monitoring the activity of disease and patient’s response to treatment and antibiotics during a bacterial infection, and after surgery for aid to diagnosisand monitoring of complications, in patients.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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