Singapore HSA registration DE0505337
Abbott Alinity m HCV AMP
Singapore·CLASS D IVD·Abbott Molecular Inc·Registered January 12, 2021Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0505337
- Registration Date
- January 12, 2021
- Change Notification Approval Date
- August 29, 2024
- Retention Due Date
- January 11, 2026
Product description
The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma. The Alinity m HCV assay is intended for use in the clinical management of HCV-infected patients undergoing antiviral therapy in conjunction with clinical presentation and other laboratory markers. The Alinity m HCV assay may also be used as a diagnostic test to confirm active HCV infection. The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings. This assay is not intended to be used in screening blood, blood products, tissue, or organ donors for HCV
Product Owner
- Short Name
- Abbott Molecular Inc
- Address
- 1300 E. Touhy Avenue, Des Plaines, IL 60018, 224-361-7000, UNITED STATES
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)
- Alinity m HCV Application Specification File Alinity m HCV CAL Kit Alinity m HCV CTRL Kit Alinity m HCV AMP Kit
- Model Identifier(s)
- 08N50-01C 08N50-070 08N50-080 08N50-090
About this record
Access comprehensive regulatory information for Abbott Alinity m HCV AMP 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 DE0505337 and owned by Abbott Molecular Inc. The device was registered on January 12, 2021.
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