Multiple-bacteria IVDs - ARTG 480785
Access comprehensive regulatory information for Multiple-bacteria IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 480785 and sponsored by Elitechgroup Australia Pty Ltd, manufactured by ELITechGroup SpA in Italy. The device registration started on February 25, 2025.
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 product UroGen ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used as a qualitative multiplex nucleic acids Real-Time PCR assay for the detection and identification of the genomic DNA of Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum, extracted from clinical specimens. The product is intended for use as an aid in the diagnosis of urogenital tract infections in patients suspected of having Mycoplasma hominis, Ureaplasma urealyticum or Ureaplasma parvum infection.