Acon Laboratories Distinct® Pregnancy Rapid Test - HSA Registration DE0507140
Access comprehensive regulatory information for Acon Laboratories Distinct® Pregnancy Rapid Test 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 DE0507140 and owned by ACON Laboratories, Inc.. The device was registered on August 02, 2022.
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.
A rapid, one-step lateral flow immunoassay in cassette and midstream format for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of two monoclonal hCG antibodies to selectively detect elevated levels of hCG.