HSA · registration DE0508788Abbott Alinity i Active-B12 (Holotranscobalamin)
SingaporeImmunologyClass BAbbott GmbH
Official record identity
- Registration number
- DE0508788
- Model name
- 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
- 09P26-1D; 09P2602; 09P2611; 09P2625; 09P2635
- Registration date
- December 26, 2023
- Source update date
- January 23, 2026
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Abbott GmbH
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Official 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.
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.