Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · R-Biopharm Pty Ltd · Diesse Diagnostica Senese SPA · Class IIb · Started September 17, 2015

Good Name: R-Biopharm 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

Start Date: September 17, 2015
Effective Date: September 17, 2015

Sponsor

Name: R-Biopharm Pty Ltd

Manufacturer

Name: Diesse Diagnostica Senese SPA
Country: Italy
Address: Strada Dei Laghi 39, Monteriggioni, 53035

Intended purpose

Intended to provide information about infection with or exposure to Herpes simplex virus 1 and/or Herpes simplex virus 2

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 sponsored by R-Biopharm Pty Ltd, manufactured by Diesse Diagnostica Senese SPA in Italy. The device registration started on September 17, 2015.

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.