HIV 1/2 antibody (anti-HIV Ab), RDT (Rapid Diagnostic Test), self-testing

Primary use
Diagnosis / Measurement / Monitoring
Type of medical device or related product
In vitro diagnostic tests
Multiple vs. specific use (health condition)
Multiple
Intended population age
Adults (20 to 64 years)
Later adults (over 64 years)
Intended population sex
All
Level of technical knowledge
Basic
Capital
No
Reusable
No
Requirements
None
WHO list of priority medical devices
Cancer management (2017)
Cardiovascular diseases and diabetes (2021)
COVID-19 (2020)
Reproductive, maternal, newborn and child health (2015)
Service delivery platforms / Healthcare levels
Community services for primary care
General outpatient (health post, health center) and outreach services for primary care
Healthcare unit
Outpatient care
EMDN related code(s)
W0105090302
HIV 1/2 - RT & POC
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)
65848
HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing (A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) 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 intended to be used for self-testing by a layperson in the home or similar environment.)
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 2005-2025 
WHO related resources
Decommissioning
WHO resources on medical devices