Singapore HSA registration DE0507538
Abbott Alinity i Anti-HCV
Singapore·CLASS D IVD·Abbott GmbH·Registered November 25, 2022Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0507538
- Registration Date
- November 25, 2022
- Retention Due Date
- November 24, 2025
Product description
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
- 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)
- 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(s)
- 08P06-3A 08P0602 08P0611 08P0623 08P0633
About this record
Access comprehensive regulatory information for Abbott Alinity i Anti-HCV 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 DE0507538 and owned by Abbott GmbH. The device was registered on November 25, 2022.
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