Device Category Dossier

CT799 - Treponema (syphilis) IVDs

Device Category Dossier for CT799 - Treponema (syphilis) IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Syphilis serology tests detect either reagin antibodies through nontreponemal flocculation or antibodies to Treponema pallidum through lateral-flow immunoassay in human serum, plasma, or whole blood samples. These tests serve as aids in diagnosing Treponema pallidum infection in adults by detecting antibodies produced in response to infection, with results typically available within minutes in clinical laboratories, emergency departments, or physicians' offices.