HSA · registration DE0504345Abbott Alinity i Galectin-3
SingaporeImmunologyClass BAbbott GmbH
Official record identity
- Registration number
- DE0504345
- Model name
- Alinity i Galectin-3 Assay File; Alinity i Galectin-3 Calibrators; Alinity i Galectin-3 Controls; Alinity i Galectin-3 Reagent Kit
- Model identifier
- 09P60-1A; 09P6001; 09P6010; 09P6022
- Registration date
- April 08, 2020
- Source update date
- August 16, 2022
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 Galectin-3 assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of galectin-3 in human serum and EDTA plasma on the Alinity i analyzer. The Alinity i Galectin-3 assay is to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF).
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.