HSA · registration DE0509787Abbott Alinity m HSV 1 & 2/ VZV
- Registration number
- DE0509787
- Model name
- 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
- 09N61-01A; 09N61-080; 09N61-090
- Registration date
- September 16, 2024
- Risk class
- Class C
- Product owner
- Abbott Molecular Inc
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
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 address
- 1300 E. Touhy Avenue, Des Plaines, IL, 60018, United States
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.