Singapore HSA registration DE0505184
Abbott Alinity m HBV AMP
Singapore·CLASS C IVD·Abbott Molecular Inc·Registered November 30, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0505184
- Registration Date
- November 30, 2020
- Change Notification Approval Date
- September 27, 2023
- Retention Due Date
- November 29, 2025
Product description
The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum. The Alinity m HBV assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing and monitoring response to treatment. The results from the Alinity m HBV 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 HBV, or as a diagnostic test to confirm the presence of HBV infection.
Product Owner
- Short Name
- Abbott Molecular Inc
- Address
- 1300 E. Touhy Avenue, Des Plaines, IL, 60018, 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 HBV Application Specification File Alinity m HBV CAL Kit Alinity m HBV CTRL Kit Alinity m HBV AMP Kit
- Model Identifier(s)
- 08N47-01D 08N47-070 08N47-080 08N47-090
About this record
Access comprehensive regulatory information for Abbott Alinity m HBV AMP in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0505184 and owned by Abbott Molecular Inc. The device was registered on November 30, 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 C IVD