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Abbott Diagnostics Korea Bioline™ H. Pylori Ag - HSA Registration DE0506943

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.

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CLASS B IVD
DE0506943
Abbott Diagnostics Korea Bioline™ H. Pylori Ag
HSA Registration Number: DE0506943
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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.

Device 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 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