RPR-DAT ADVANCED

Primary DI

08033891328412

Basic UDI-DI Code

803389132RPRD-A00YC

Reference

26031

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

DIESSE Diagnostica Senese S.p.A

"RPR-DAT ADVANCED (REF 26031) is a non-treponemal agglutination assay for the qualitative and semi-quantitative detection of reagines in human serum to be applied to the AUTO-DAT (REF 26001) instrument. Because non-treponemal tests are based on the detection of reagines, a class of antibodies found in Syphilis (a disease caused by Treponema pallidum infection), the kit is intended to determine exposure to Treponema pallidum infection and to be used as an aid in its diagnosis. The test is not intended to be used to detect exposure to Treponema pallidum infection in blood, blood components, cells, tissues, organs, or any derivatives thereof in order to assess their suitability for transfusion, transplantation, or cell administration. It should only be used by professional laboratory personnel."

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