HSA · registration DE0504600Abbott Architect Anti-HCV Assay (LN 6C37)
- Registration number
- DE0504600
- Model name
- ARCHITECT Anti-HCV Calibrator; ARCHITECT Anti-HCV Controls; ARCHITECT Anti-HCV Reagent Kit; ARCHITECT Anti-HCV Reagent Kit; ARCHITECT Anti-HCV Reagent Kit
- Model identifier
- 6C37-02; 6C37-15; 6C37-28; 6C37-33; 6C37-38
- Registration date
- June 15, 2020
- Source update date
- October 28, 2021
- Risk class
- Class D
- Product owner
- Abbott GmbH
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
The ARCHITECT Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) 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). The ARCHITECT 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.