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Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs - ARTG 460827

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.

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Class IIb
ARTG 460827
Class IIb
Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
ARTG ID: 460827
Good Name: Siemens Healthcare Pty Ltd - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
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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).

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
Manufacturer
Country
United States of America
Address
511 Benedict Avenue, Tarrytown, NY, 10591