Australia flagARTG 393812

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

ARTG ID: 393812 · 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
ARTG ID
393812
Start Date
August 11, 2022
Effective Date
August 11, 2022
Sponsor
Manufacturer
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 registered under ARTG number 393812 and 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.

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