TPHA-DAT ADVANCED

Primary DI

08033891328429

Basic UDI-DI Code

803389132TPHAD00ND

Reference

26041

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

DIESSE Diagnostica Senese S.p.A

"TPHA-DAT ADVANCED (REF 26041) is a hemagglutination test for the semi-quantitative detection of specific antibodies directed against Treponema pallidum. The test is performed on human serum by passive hemagglutination using the AUTO-DAT instrument (REF 26001). The kit is intended to determine exposure to Treponema pallidum infection and to be used as an aid in the diagnosis of Syphilis. The test is not intended to be used to detect exposure to Treponema pallidum infection in blood, blood components, cells, tissues, organs, or any derivative thereof for the purpose of assessing their suitability for transfusion, transplantation, or cell administration. It should be used only by professional laboratory personnel."

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