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Singapore HSA registration DE0503883

Biokit Alinity c ASO

Singapore flagSingapore·CLASS B IVD·Biokit S.A.·Registered December 03, 2019
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0503883
Registration Date
December 03, 2019
Retention Due Date
December 02, 2025
Product description
The Alinity c ASO assay is used for the quantitative determination of antistreptolysin-O in human serum on the Alinity c analyzer.
Product Owner
Name
Biokit S.A.
Short Name
Biokit S.A.
Address
Biokit S.A., Av. Can Montcau 7, 08186 Lliçà d'Amunt, Barcelona, SPAIN
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
Model Name(s)
Alinity c ASO Assay File Alinity c ASO Standard Alinity c ASO Reagent Kit Alinity c ASO Reagent Kit Alinity c ASO-RF Control I Kit Alinity c ASO-RF Control II Kit
Model Identifier(s)
01R06-1A 01R0601 01R0620 01R0630 04S0910 04S0911
About this record

Access comprehensive regulatory information for Biokit Alinity c ASO 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 DE0503883 and owned by Biokit S.A.. The device was registered on December 03, 2019.

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 B IVD