ARTG 460827

Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

ARTG ID: 460827 · Siemens Healthcare Pty Ltd · Siemens Healthcare Diagnostics Inc · Class IIb · Started August 27, 2024

Good Name: Siemens Healthcare Pty Ltd - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

ARTG ID: 460827
Start Date: August 27, 2024
Effective Date: August 27, 2024

Sponsor

Name: Siemens Healthcare Pty Ltd

Manufacturer

Name: Siemens Healthcare Diagnostics Inc
Country: United States of America
Address: 511 Benedict Avenue, Tarrytown, NY, 10591

Intended purpose

For in vitro diagnostic use in testing to provide information about infection with or exposure to Herpes simplex virus 1 (HSV1) and/or Herpes simplex virus 2 (HSV2).

About this record

Access comprehensive regulatory information for Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 460827 and sponsored by Siemens Healthcare Pty Ltd, manufactured by Siemens Healthcare Diagnostics Inc in United States of America. The device registration started on August 27, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.