Pure Global

Mycobacteria IVDs

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
Class IIb
Mycobacteria IVDs
Australia TGA ARTG Registered Device
Good Name: Revvity Pty Ltd - Mycobacteria IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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
Manufacturer
Country
United Kingdom
Address
143 Park Drive East Milton Park, Abingdon, Oxfordshire, OX14 4SE