Singapore HSA registration DE0508132
Abbott Alinity m SARS-CoV-2
Singapore·CLASS D IVD·Abbott Molecular Inc·Registered May 26, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0508132
- Registration Date
- May 26, 2023
- Change Notification Approval Date
- August 29, 2024
- Retention Due Date
- May 25, 2025
Product description
The Alinity m SARS-CoV-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare provider, from patients suspected of COVID-19 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 SARS-CoV-2 Application Specification File Alinity m SARS-CoV-2 CTRL Kit Alinity m SARS-CoV-2 AMP Kit
- Model Identifier(s)
- 09N78-01F 09N78-080 09N78-090
About this record
Access comprehensive regulatory information for Abbott Alinity m SARS-CoV-2 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 DE0508132 and owned by Abbott Molecular Inc. The device was registered on May 26, 2023.
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