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Singapore HSA registration DE0508788

Abbott Alinity i Active-B12 (Holotranscobalamin)

Singapore flagSingapore·CLASS B IVD·Abbott GmbH·Registered December 26, 2023
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0508788
Registration Date
December 26, 2023
Retention Due Date
December 25, 2025
Product description
The Alinity i Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of Holotranscobalamin in human serum on the Alinity i analyzer. The Alinity i Active-B12 (Holotranscobalamin) assay is to be used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Product Owner
Name
Abbott GmbH
Short Name
Abbott GmbH
Address
Max-Planck-Ring 2, 65205 Wiesbaden, GERMANY
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 i Active-B12 assay file Alinity i Active-B12 (Holotranscobalamin) Calibrators Alinity i Active-B12 (Holotranscobalamin) Controls Alinity i Active-B12 (Holotranscobalamin) Reagent Kit Alinity i Active-B12 (Holotranscobalamin) Reagent Kit
Model Identifier(s)
09P26-1C 09P2602 09P2611 09P2625 09P2635
About this record

Access comprehensive regulatory information for Abbott Alinity i Active-B12 (Holotranscobalamin) 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 DE0508788 and owned by Abbott GmbH. The device was registered on December 26, 2023.

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