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Abbott Diagnostics Korea Bioline™ TB Ag MPT64 - HSA Registration DE0506973

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.

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CLASS C IVD
DE0506973
Abbott Diagnostics Korea Bioline™ TB Ag MPT64
HSA Registration Number: DE0506973
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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.

Device 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 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