Singapore HSA registration DE0504600
Abbott Architect Anti-HCV Assay (LN 6C37)
Singapore·CLASS D IVD·Abbott GmbH·Registered June 15, 2020Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0504600
- Registration Date
- June 15, 2020
- Change Notification Approval Date
- August 22, 2022
- Retention Due Date
- June 14, 2025
Product description
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
- Name
- Abbott GmbH
- Short Name
- Abbott GmbH
- Address
- Max-Planck-Ring 2, 65205 Wiesbaden, GERMANY
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- 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(s)
- 6C37-02 6C37-15 6C37-28 6C37-33 6C37-38
About this record
Access comprehensive regulatory information for Abbott Architect Anti-HCV Assay (LN 6C37) in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0504600 and owned by Abbott GmbH. The device was registered on June 15, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD