Rapid Diagnostic Immunodeficiency Virus (HIV), kit

Type of medical device or related product
General vs. specific use (health condition)
Intended population age
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
EMDN related code(s)
W0105090303
HIV AG/AB COMBI - RT & POC
GMDN related code(s)
48447
HIV1/HIV2 antigen/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 antigens from and 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 used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.)