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

Primary use
Diagnosis / Measurement / Monitoring
Type of medical device or related product
In vitro diagnostic tests
General vs. specific use (health condition)
Specific
Intended population age
Later adults (over 64 years)
Adults (20 to 64 years)
Adolescent (10 to 19 years)
Childhood (28 days to 9 years)
Intended population sex
All
Level of technical knowledge
Specialized clinical
Capital
No
Reusable
No
Requirements
None
WHO list of priority medical devices
Reproductive, maternal, newborn and child health (2015)
Service delivery platforms / Healthcare levels
First-level (district) hospital services
General outpatient (health post, health center) and outreach services for primary care
Second-level and third-level hospital services and specialized outpatient services
Healthcare unit
Emergency care
Inpatient care
Intensive care
Laboratory
Outpatient care
EMDN related code(s)
W01050103
SYPHILIS (TREPONEMA PALLIDUM)
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
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.)
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024 
Decommissioning
WHO resources on medical devices