HSA · registration DE0507538Abbott Alinity i Anti-HCV
- Registration number
- DE0507538
- Model name
- Anti-HCVII Assay file; Alinity i Anti-HCV Calibrator; Alinity i Anti-HCV Controls; Alinity i Anti-HCV Reagent Kit; Alinity i Anti-HCV Reagent Kit
- Model identifier
- 08P06-3A; 08P0602; 08P0611; 08P0623; 08P0633
- Registration date
- November 25, 2022
- Source update date
- May 15, 2026
- Risk class
- Class D
- Product owner
- Abbott GmbH
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
The Alinity i Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibody to Hepatitis C virus (anti-HCV) in human serum and plasma, including specimens collected post mortem (non-heart beating) on the Alinity i analyzer. The Alinity i Anti-HCV assay is intended to be used as an aid in the diagnosis of Hepatitis C infection and as a screening test to prevent transmission of Hepatitis C virus (HCV) to recipients of blood, blood components, cells, tissue and organs.
- Product owner address
- Max-Planck-Ring 2, 65205 Wiesbaden, Germany
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
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.