Singapore HSA registration DE0506943
Abbott Diagnostics Korea Bioline™ H. Pylori Ag
Singapore·CLASS B IVD·Abbott Diagnostics Korea Inc.·Registered June 08, 2022Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506943
- Registration Date
- June 08, 2022
- Retention Due Date
- June 07, 2025
Product description
The Bioline™ H.pylori Ag test it is a rapid test for the qualitative detection of H. pylori antigen in human fecal specimens. This test kit is intended as an aid in the diagnosis of H.pylori infection in patients with gastrointestinal symptoms.
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 H. Pylori Ag
- Model Identifier(s)
- 04FK20
About this record
Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ H. Pylori Ag 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 DE0506943 and owned by Abbott Diagnostics Korea Inc.. The device was registered on June 08, 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 B IVD