Newbio TPHA 200

Primary DI

05060515140085

Basic UDI-DI Code

506051514TPHA7L

Reference

NB008

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 Treponema pallidum IgG and IgM antibodies to syphilis in human serum or EDTA plasma and to determine the titre level of the samples. 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 6 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).