Singapore HSA registration DE0509697
Siemens Atellica IM® Herpes-2 IgG (HSV2)
Singapore·CLASS C IVD·Siemens Healthcare Diagnostics Inc·Registered August 28, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509697
- Registration Date
- August 28, 2024
- Retention Due Date
- August 27, 2025
Product description
The Atellica IM® Herpes-2 IgG (HSV2) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. This assay is intended for use as an aid in the determination of serological status to HSV-2 and in the diagnosis of herpes simplex virus infection.
Product Owner
- Short Name
- Siemens Healthcare, USA
- Address
- 511 Benedict Avenue, Tarrytown, NY 10591, UNITED STATES
Registrant
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- Atellica IM Herpes-2 IgG (HSV2) Atellica IM Herpes-2 IgG Quality Control
- Model Identifier(s)
- 10733033 10733034
About this record
Access comprehensive regulatory information for Siemens Atellica IM® Herpes-2 IgG (HSV2) 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 DE0509697 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on August 28, 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