Cytomegalovirus (Human herpesvirus 5) IVDs - ARTG 471668
Access comprehensive regulatory information for Cytomegalovirus (Human herpesvirus 5) IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 471668 and sponsored by Elitechgroup Australia Pty Ltd, manufactured by ELITechGroup SpA in Italy. The device registration started on December 04, 2024.
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 CMV RNA ELITe MGB® Kit product is an in vitro diagnostic medical device intended to be used by healthcare professionals as quantitative nucleic acids reverse transcription and Real-Time PCR assay for the detection and quantification of the human Cytomegalovirus virion mRNA (CMV RNA) extracted from non-cellular clinical specimens. The assay is validated in association with the ELITe InGenius® instrument, an automated and integrated system for extraction, reverse transcription, Real-Time PCR and results interpretation, using human specimens of plasma collected in EDTA.