Intended use: The Cypress Diagnostics kit TPHA is an in vitro diagnostic medical device intended to be used for the qualitative detection of Treponema pallidum IgG and IgM antibodies in human serum and EDTA plasma.

The device is not automated.

The detection of Treponema pallidum IgG and IgM antibodies is intended to be used to aid in the diagnosis of syphilis.

The target population are patients with a suspected syphilis infection or at elevated risk of syphilis infection.

This assay is not intended for blood screening or as a confirmatory assay on donor samples.

This kit is intended to be used by healthcare professionals in a laboratory-based testing environment. 200 pcs