Lyfstone Calprotectin (CLP) quantitative test

Primary DI

07090028590013

Basic UDI-DI Code

B-07090028590013

Reference

LYFCLP001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Calpro AS

The Lyfstone® Calprotectin for Synovial Fluid test is a method for risk strat- ification of infection in suspected periprosthetic joint infection (PJI) patients by determination of the calprotectin (CLP) level in human synovial fluid samples in combination with the dedicated Lyfstone® smartphone application. The test is intended as a diagnostic aid for screening of suspected PJI patients in a patient near setting or a laboratory. The test is for professional use only.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).