EUROIMMUN Anti-Zinc Transporter 8 ELISA - HSA Registration DE0510294
Access comprehensive regulatory information for EUROIMMUN Anti-Zinc Transporter 8 ELISA 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 DE0510294 and owned by EUROIMMUN Medizinische Labordiagnostika AG. The device was registered on January 31, 2025.
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.
The enzyme immunoassay (ELISA) provides quantitative in vitro determination of human autoantibodies against zinc transporter 8 (ZnT8) in serum or plasma to support the diagnosis of type 1 diabetes mellitus (insulin-dependent diabetes mellitus, IDDM). The product is designed for use as IVD.