CHORUS tTg-A

Primary DI

08033891329358

Basic UDI-DI Code

803389132CHORUSTTGA00FR

Reference

86058/12

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

DIESSE Diagnostica Senese S.p.A

CHORUS tTg-A (REF. 86058 - 86058/12) is an immunoassay kit for automated semi-quantitative determination of IgA class antibodies against tissue Transglutaminase. Since anti-tTg antibodies show a high sensitivity and specificity for celiac disease, the kit is used as an aid to the related diagnosis and monitoring. The test, performed in human serum using a disposable device applied to the CHORUS/CHORUS TRIO/CHORUS EVO instruments, must be used by professional laboratory users only. It must be used by professional laboratory users only. The test is not intended to detect the exposure of the transmissible agent in blood, blood components, cells, tissues, organs or any derivative thereof for the purpose of assessing its suitability for transfusion, transplantation or cell administration.

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).