MeMed BV®

Primary DI

17290018739010

Basic UDI-DI Code

729001873901CU

Reference

FG10001

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

MeMed Diagnostics Ltd.

The MeMed BV® test is an automated semi-quantitative immunoassay for professional clinical use only that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum and venous whole blood samples. The Test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The Test is indicated for use in patients presenting to a medical center and inpatients with suspected acute bacterial or viral infection. The MeMed BV® test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV® test is intended for in vitro diagnostic use only. The test is not intended as a standalone diagnostic test for antimicrobial prescription. The test is not intended for patients being admitted to the Intensive Care Unit or to be used for near patient testing.

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