Instrument/analyser IVDs
Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Revvity Pty Ltd, manufactured by Revvity Singapore Pte Ltd in Singapore. The device registration started on August 28, 2023.
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.
The intended purpose of the WIZARD2 instrument is to detect and count gamma radiation emitted from solid and liquid samples, that were prepared through the addition of a radioactive reagent for downstream clinical applications. The instrument is intended to be used by trained laboratory personnel. WIZARD2™ automatic gamma counters are designed for counting performance with all types of samples and for every gamma counting application. Unique well-type detectors and sample changer system, advanced robotics, and highly effective lead shielding result in high counting efficiency, low background and minimal crosstalk. An operating system with touch screen for easy and fast instrument operation of routine tasks makes WIZARD2 very user-friendly. The instrument supports in vitro diagnostic use in clinical laboratories and is optionally available as 21CFR Part 11 compatible to fulfill pharmaceutical industry requirements. There are two basic WIZARD2 counter models, 2470 WIZARD2 automatic gamma counter and 2480 WIZARD2 automatic gamma counter. Additionally, 2470 WIZARD2 is available in a number of different configurations.