Singapore HSA registration DE0506973
Abbott Diagnostics Korea Bioline™ TB Ag MPT64
Singapore·CLASS C IVD·Abbott Diagnostics Korea Inc.·Registered June 17, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506973
- Registration Date
- June 17, 2022
- Retention Due Date
- June 16, 2025
Product description
Bioline™ TB Ag MPT64 is a rapid immunochromatographic identification test for the M. tuberculosis complex that use mouse monoclonal anti-MPT64. This test kit can be easily used for rapid identification of the M. tuberculosis complex in combination with culture systems based on liquid media without any technical complexity in clinical laboratories.
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 TB AgMPT64
- Model Identifier(s)
- 08FK50
About this record
Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ TB Ag MPT64 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 DE0506973 and owned by Abbott Diagnostics Korea Inc.. The device was registered on June 17, 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