EUROIMMUN Anti-Collagen type VII ELISA (IgG) - HSA Registration DE0509678
Access comprehensive regulatory information for EUROIMMUN Anti-Collagen type VII ELISA (IgG) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509678 and owned by EUROIMMUN Medizinische Labordiagnostika AG. The device was registered on August 23, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Epidermolysis bullosa aquisita (EBA). The ELISA test kit provides a semiquantitative or quantitative in vitro assay for the determination of human autoantibodies of the immunoglobulin class IgG against collagen type VII. The test kit contains microtiter strips each with 8 individual break-off reagent wells coated with collagen type VII. In the first reaction step, diluted patient samples are incubated in the wells. In the case of positive samples, the specific IgG antibodies (also IgA and IgM) will bind to the corresponding antigenic site. To detect the bound antibodies, a second incubation is carried out using an enzyme-labelled anti-human IgG (enzyme conjugate) catalysing a colour reaction.