Reagents, CD4 enumeration, POC

Primary use
Diagnosis / Measurement / Monitoring
Type of medical device or related product
Solutions and reagents
General vs. specific use (health condition)
General
Intended population sex
All
Level of technical knowledge
Specialized clinical
Capital
No
Reusable
Yes
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
Laboratory
EMDN related code(s)
W01
REAGENTS
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)
63165
CD4 cell marker 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 CD4 cell marker 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 aid in the management of patients with pre-diagnosed human immunodeficiency virus (HIV) infection. 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