HSA · registration DE0506690Abbott Alinity s Anti-HCV II
- Registration number
- DE0506690
- Model name
- Alinity s Anti-HCV II Assay File; Alinity s Anti-HCV II Calibrator Kit; Alinity s Anti-HCV II Assay Control Kit; Alinity s Anti-HCV II Release Control Kit; Alinity s Anti-HCV II Reagent Kit; Alinity s Anti-HCV II Reagent Kit
- Model identifier
- 04W56-1D; 04W5602; 04W5610; 04W5612; 04W5655; 04W5656
- Registration date
- March 03, 2022
- Source update date
- July 04, 2024
- Risk class
- Class D
- Product owner
- Abbott GmbH
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma, including specimens collected postmortem (non-heart-beating), on the Alinity s System. The Alinity s Anti-HCV II assay is intended to be used as an aid in the diagnosis of HCV infection and as a screening test to prevent transmission of HCV to recipients of blood, blood components, cells, tissues, 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.