Bio-Rad BioPlex 2200 Celiac IgA and IgG - HSA Registration DE0503769
Access comprehensive regulatory information for Bio-Rad BioPlex 2200 Celiac IgA and 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 DE0503769 and owned by Bio-Rad Laboratories, Inc.. The device was registered on October 23, 2019.
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 BioPlex® 2200 Celiac IgA and IgG kits are multiplex flow immunoassays intended for the semi-quantitative detection of IgA and IgG autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum or EDTA plasma. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy) and the associated skin disorder Dermatitis Herpetiformis (DH). The BioPlex 2200 Celiac IgA and IgG Reagent kits are intended for use with the Bio-Rad BioPlex 2200 System.