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Singapore HSA registration DE0506929

Abbott Diagnostics Korea Bioline™ Dengue IgG Capture ELISA

Singapore flagSingapore·CLASS C IVD·Abbott Diagnostics Korea Inc.·Registered June 03, 2022
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0506929
Registration Date
June 03, 2022
Retention Due Date
June 02, 2025
Product description
Bioline™ Dengue IgG Capture ELISA kit is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies specific to Dengue virus in human serum. The Bioline™ Dengue IgG Capture ELISA kit is intended for professional use as an aid on the diagnosis of dengue virus infection and reactive samples should be confirmed by a supplemental assay such as RT-PCR and HAI (Hemagglutination inhibition) test as gold standard.
Product Owner
Name
Abbott Diagnostics Korea Inc.
Short Name
Abbott Diagnostics Korea Inc.
Address
65, Borahagal-ro, Giheung-gu,, Yongin-si, Gyeonggi-do 17099, KOREA, REPUBLIC OF
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
DCH AURIGA SINGAPORE
Address
10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
Model Name(s)
Bioline™ Dengue IgG Capture ELISA
Model Identifier(s)
11EK10
About this record

Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ Dengue IgG 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 DE0506929 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD