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Singapore HSA registration DE0508789

Abbott ARCHITECT 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
DE0508789
Registration Date
December 26, 2023
Retention Due Date
December 25, 2025
Product description
The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of Holotranscobalamin in human serum on the ARCHITECT iSystem. Active-B12 (Holotranscobalamin) is 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)
ARCHITECT Active-B12 (Holotranscobalamin) Calibrators ARCHITECT Active-B12 (Holotranscobalamin) Controls ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit
Model Identifier(s)
3P24-02 3P24-11 3P24-28 3P24-38
About this record

Access comprehensive regulatory information for Abbott ARCHITECT 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 DE0508789 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