Abbott Diagnostics Medical Determine™ HIV Early Detect - HSA Registration DE0506959
Access comprehensive regulatory information for Abbott Diagnostics Medical Determine™ HIV Early Detect in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0506959 and owned by Abbott Diagnostics Medical Co., Ltd.. The device was registered on June 15, 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.
Determine™ HIV Early Detect is an in vitro, visually read, qualitative immunoassay for the detection of antibodies (Ab) to HIV-1 and HIV-2 and the detection of non-immunocomplexed(free) HIV-1 p24 antigen (Ag) in human capillary and venous whole blood, plasma or serum. The test is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection in individuals with suspected infection. Reactivity on 1) the Ab bar alone 2) the Ag bar alone or 3) both, the Ab and Ag bars simultaneously, is considered a reactive result suggestive of infection with HIV. The test is for professional use only. A reactive/positive HIV test result must be followed by confirmatory testing before a final diagnosis of HIV infection can be made.