Australia TGA ARTG record

Specimen receptacle IVDs

Australia TGA ARTG Registered Device · AVSEC CONSULTING PTY LIMITED · TERABio Tech Ltd · Class I · Started August 09, 2021

Good Name: AVSEC CONSULTING PTY LIMITED - Specimen receptacle IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: August 09, 2021
Effective Date: August 09, 2021

Sponsor

Name: AVSEC CONSULTING PTY LIMITED

Manufacturer

Name: TERABio Tech Ltd
Country: Israel
Address: 60 Eli Landau Blvd, Hertzliya, 4685160

Intended purpose

The TERAtube is a container intended to contain a specimen of air exhaled from a patient for subsequent in vitro determination of chemical and/or biological markers (e.g., volatile organic compounds) in the specimen to aid metabolic profiling or the diagnosis of disorders [for example, lipid peroxidation levels, gastrointestinal H. pylori infection, coronavirus disease (COVID-19) infection]. It may include a port for blowing into the container, an access device (e.g., tubing) to facilitate specimen collection, and/or an adaptor for connection to an analyser. This is a single-use device.

About this record

Access comprehensive regulatory information for Specimen receptacle IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by AVSEC CONSULTING PTY LIMITED, manufactured by TERABio Tech Ltd in Israel. The device registration started on August 09, 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.