SARS CoV-2 antigen, RDT (Rapid Diagnostic Test)

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)
Adolescent (10 to 19 years)
Intended population sex
All
Level of technical knowledge
Specialized clinical
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)
W0105099099
VIROLOGY - RT & POC - OTHER
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)
64787
SARS-CoV-2 antigen 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 antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), 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. 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 2005-2025 
WHO related resources
Decommissioning
WHO resources on medical devices