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Abbott Diagnostics Korea Bioline™ Dengue IgM Capture ELISA - HSA Registration DE0506928

Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ Dengue IgM Capture ELISA 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 DE0506928 and owned by Abbott Diagnostics Korea Inc.. The device was registered on June 03, 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
DE0506928
Abbott Diagnostics Korea Bioline™ Dengue IgM Capture ELISA
HSA Registration Number: DE0506928
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Product Description

The Bioline™ Dengue IgM Capture ELISA kit is an enzyme-linked immunosorbent assay for the qualitative detection of IgM antibodies specific to dengue virus in human serum. The Bioline™Dengue IgM Capture ELISA kit is intended for professional use as an aid in the diagnosis of dengue virus infection, and reactive samples should be confirmed by a supplemental gold standard assay such as RT-PCR or HI (hemagglutination inhibition).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0506928
Registration Date
June 03, 2022
Retention Due Date
June 02, 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™ Dengue IgM Capture ELISA
Model Identifier(s)
11EK20