TICKPLEX

Primary DI

111745457308

Basic UDI-DI Code

B-111745457308

Reference

DT03

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Te?ted Oy

The TICKPLEX® BASIC test provides a quantitative and qualitative in vitro assay for human IgM and IgG antibodies against multiple microbial antigens in human serum or plasma. The kit tests for Borrelia afzelii, Borrelia burgdorferi, and Borrelia garinii infections and the tests include persistent antigens of the different borrelia species. The test kit and TICKPEX® BASIC analyze excel sheet are intended to aid in the diagnosis of tick-borne diseases. The test kit and TICKPEX® BASIC analyze excel sheet are for professional use only in clinical laboratory environment and are not to be used for self-testing.

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