Australia flagARTG 480808

Multiple infectious organism IVDs

ARTG ID: 480808 · Elitechgroup Australia Pty Ltd · ELITechGroup SpA · Class IIb · Started February 25, 2025

Good Name: Elitechgroup Australia Pty Ltd - Multiple infectious organism IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
480808
Start Date
February 25, 2025
Effective Date
February 25, 2025
Sponsor
Manufacturer
Country
Italy
Address
Corso Svizzera 185, Torino, 10149
Intended purpose

The product STI PLUS ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used b as qualitative multiplex nucleic acids Real-Time PCR assay for the detection and identification of the DNA of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis 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 Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium or Trichomonas vaginalis infections.

About this record

Access comprehensive regulatory information for Multiple infectious organism IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 480808 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.

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