Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Abbott Australasia Pty Ltd Diagnostic Division · Abbott Ireland Diagnostics Division · Class IIb · Started August 11, 2022

Good Name: Abbott Australasia Pty Ltd Diagnostic Division - 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: August 11, 2022
Effective Date: August 11, 2022

Sponsor

Name: Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Name: Abbott Ireland Diagnostics Division
Country: Ireland
Address: Finisklin Business Park, SLIGO

Intended purpose

For the determination of Herpes simplex virus 1 and/or Herpes simplex virus 2 (HSV1 and/or HSV2) markers in human clinical specimens.

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 Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Ireland Diagnostics Division in Ireland. The device registration started on August 11, 2022.

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.