Abbott Diagnostics Korea Bioline™ Malaria Ag P.f/Pan - HSA Registration DE0506918
Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ Malaria Ag P.f/Pan in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506918 and owned by Abbott Diagnostics Korea Inc.. The device was registered on May 31, 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.
Bioline™ Malaria Ag P.f/Pan test kit intended for the detection of Malaria infection in human blood specimen, indicating qualitative and differential diagnosis between HRP2 (Histidine-rich protein II) specific to Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) specific to Plasmodium species (Pan) in human blood specimen. Bioline™ Malaria Ag P.f/Pan test is intended for professional use, only for an initial screening test and reactive specimens should be confirmed by a supplemental assay such as microscopic examination of thin blood smear.