Australia TGA ARTG record

Mycobacteria IVDs

Australia TGA ARTG Registered Device · Revvity Pty Ltd · Oxford Immunotec Ltd · Class IIb · Started December 24, 2021

Good Name: Revvity Pty Ltd - Mycobacteria IVDs

Device classification

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

Registration information

Start Date: December 24, 2021
Effective Date: December 24, 2021

Sponsor

Name: Revvity Pty Ltd

Manufacturer

Name: Oxford Immunotec Ltd
Country: United Kingdom
Address: 143 Park Drive East Milton Park, Abingdon, Oxfordshire, OX14 4SE

Intended purpose

The T-SPOT.TB test is an in vitro diagnostic test for the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens and is intended for use as an aid in the diagnosis of tuberculosis (TB) infection. The T-SPOT.TB test is a simplified enzyme-linked immunospot (ELISPOT) method which enumerates individual TB-specific activated effector T cells.

About this record

Access comprehensive regulatory information for Mycobacteria IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Revvity Pty Ltd, manufactured by Oxford Immunotec Ltd in United Kingdom. The device registration started on December 24, 2021.

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.