RPR-DAT

Primary DI

08033891323936

Basic UDI-DI Code

803389132TREPONEMADAT0048

Reference

26030

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 (REF 26030) is an agglutination test kit for qualitative detection of reagins in human serum, to be applied on the AUTO-DAT instrument or to be used in manual technique. The test may also be used to detect reagins in samples serially diluted to establish titer information (semi-quantitative test). Since non-treponemal tests are based on the detection of reagins, an antibody class present in Syphilis (disease caused by Treponema pallidum infection), the kit is intended to determine the exposure to Treponema pallidum infection and to be used as an aid to the related diagnosis.

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