Test, Treponemal, Rapid Diagnostic Test (RDT), kit

Type of medical device or related product
General vs. specific use (health condition)
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
EMDN related code(s)
W01050103
SYPHILIS (TREPONEMA PALLIDUM)
GMDN related code(s)
51801
Treponema pallidum total antibody IVD, kit, rapid ICT, clinical (A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to Treponema pallidum in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with Treponema pallidum, the bacteria associated with syphilis. It is not intended to be used for self-testing.)