Reagents, HBsAg RDT

Type of medical device or related product
General vs. specific use (health condition)
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
EMDN related code(s)
W01050202
HEPATITIS B VIRUS
GMDN related code(s)
48332
Hepatitis B virus e-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 Hepatitis B virus e-antigen 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.)