Phadia EliA anti-TSH-R Well - HSA Registration DE0510569
Access comprehensive regulatory information for Phadia EliA anti-TSH-R Well 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 DE0510569 and owned by Phadia AB. The device was registered on April 08, 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.
EliA anti-TSH-R is intended for the in vitro quantitative measurement of autoantibodies to the thyroid stimulating hormone receptor (TSH-R) in human serum and plasma (EDTA, heparin) using a thyroid stimulating monoclonal antibody, as an aid in the clinical diagnosis of Graves' disease (autoimmune hyperthyroidism). EliA anti-TSH-R uses the EliA anti-TSH-R method on the instrument Phadia 250. EliA products are to be used in clinical laboratories by trained professionals only.