Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)

Device typeMultiple gastrointestinal virus 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 multiple gastrointestinal viruses, which may include adenovirus and/or rotavirus, 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.

FDA categoryAntigens, Ha (Including Ha Control), Adenovirus 1-33

Device ID06974849369199

Single useYes

MRI safetyLabeling does not contain MRI Safety Information