Newbio RPR 500

Primary DI

05060515140139

Basic UDI-DI Code

506051514RPREF

Reference

NB013

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Newmarket Biomedical Ltd

Intended for the qualitative detection of reagin antibodies in human serum and EDTA plasma as an aid in the diagnosis of syphilis. The intended use population is patients with a suspected syphilis infection or at elevated risk of syphilis infection who attend STI clinics or other healthcare settings. This assay is not intended for automated use. This assay is not intended for blood screening or as a confirmatory assay on donor samples.

The Basic UDI-DI associated with this device has 4 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 C) and regulation (EU IVDR).