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HSA · registration DE0508789

Abbott ARCHITECT Active-B12 (Holotranscobalamin)

SingaporeImmunologyClass BAbbott GmbH
Verified
Official record identity
Registration number
DE0508789
Model name
ARCHITECT Active-B12 (Holotranscobalamin) Calibrators; ARCHITECT Active-B12 (Holotranscobalamin) Controls; ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit; ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit
Model identifier
3P24-02; 3P24-11; 3P24-28; 3P24-38
Registration date
December 26, 2023
Classification
Risk class
Class B
Official value: CLASS B
Published category
Immunology
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Published parties
Product owner
Abbott GmbH
Registrant / registration holder
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Official 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.

Additional source fields
Product owner address
Max-Planck-Ring 2, 65205 Wiesbaden, Germany
Registrant address
3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.