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Specimen receptacle IVDs - ARTG 372371

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 registered under ARTG number 372371 and 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.

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TGA ARTG Official Data
Class I
ARTG 372371
Class I
Specimen receptacle IVDs
ARTG ID: 372371
Good Name: AVSEC CONSULTING PTY LIMITED - Specimen receptacle IVDs
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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.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
372371
Start Date
August 09, 2021
Effective Date
August 09, 2021
Manufacturer
Country
Israel
Address
60 Eli Landau Blvd, Hertzliya, 4685160