Singapore HSA registration DE0506918
Abbott Diagnostics Korea Bioline™ Malaria Ag P.f/Pan
Singapore·CLASS C IVD·Abbott Diagnostics Korea Inc.·Registered May 31, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506918
- Registration Date
- May 31, 2022
- Retention Due Date
- May 30, 2025
Product description
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.
Product Owner
- Short Name
- Abbott Diagnostics Korea Inc.
- Address
- 65, Borahagal-ro, Giheung-gu,, Yongin-si, Gyeonggi-do 17099, KOREA, REPUBLIC OF
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
- Model Name(s)
- Bioline Malaria Control Kit Bioline Malaria P.f/Pan
- Model Identifier(s)
- 05FK10C 05FK60
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD