Bio-Rad BioPlex 2200 APLS IgG, IgM and IgA - HSA Registration DE0503768
Access comprehensive regulatory information for Bio-Rad BioPlex 2200 APLS IgG, IgM and IgA 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 DE0503768 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 Antiphospholipid Syndrome (APLS) IgG, IgM and IgA kits are multiplex flow immunoassays intended for the semiquantitative detection of IgG, IgM and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (ß2GPI) in human serum and heparinized or citrated plasma. In conjunction with other clinical findings, the test systems are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders. The BioPlex 2200 APLS IgG, IgM and IgA kits are intended for use with the Bio-Rad BioPlex 2200 System.