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Singapore HSA registration DE0506960

Abbott Diagnostics Korea Bioline™ HIV 1/2 3.0

Singapore flagSingapore·CLASS D IVD·Abbott Diagnostics Korea Inc.·Registered June 15, 2022
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0506960
Registration Date
June 15, 2022
Retention Due Date
June 14, 2025
Product description
The Bioline™ HIV 1/2 3.0 is a rapid, qualitative test for the detection of antibodies to all isotypes(IgG, IgM, IgA) specific to HIV-1 including subtypes-O and HIV-2 simultaneously in human serum, plasma or whole blood. The Bioline™ HIV 1/2 3.0 is intended only for professional use, only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as ELISA or Western Blot test.
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 HIV 1/2 3.0 Bioline HIV 1/2 3.0 Bioline HIV 1/2 3.0
Model Identifier(s)
03FK10 03FK11 03FK16
About this record

Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ HIV 1/2 3.0 in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0506960 and owned by Abbott Diagnostics Korea Inc.. The device was registered on June 15, 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 D IVD