Singapore HSA registration DE0509787
Abbott Alinity m HSV 1 & 2/ VZV
Singapore·CLASS C IVD·Abbott Molecular Inc·Registered September 16, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0509787
- Registration Date
- September 16, 2024
- Retention Due Date
- September 15, 2025
Product description
The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2), and Varicella Zoster Virus (VZV) DNA from clinician-collected lesion swab specimens(including cutaneous or mucocutaneous lesion specimens). The Alinity m HSV 1 & 2 / VZV assay is intended for use as an aid in the diagnosis of HSV-1, HSV-2 and/or VZV infections in symptomatic patients.
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 HSV 1 & 2 / VZV Application Specification File Alinity m HSV 1 & 2 / VZV CTRL Kit Alinity m HSV 1 & 2 / VZV AMP Kit
- Model Identifier(s)
- 09N61-01A 09N61-080 09N61-090
About this record
Access comprehensive regulatory information for Abbott Alinity m HSV 1 & 2/ VZV 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 DE0509787 and owned by Abbott Molecular Inc. The device was registered on September 16, 2024.
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