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Specimen receptacle IVDs

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 Kirby Institute - COVID-19 Remote Response, manufactured by Longhorn Vaccines and Diagnostics LLC in United States of America. The device registration started on May 31, 2020.

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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Class I
Class I
Specimen receptacle IVDs
Australia TGA ARTG Registered Device
Good Name: Kirby Institute - COVID-19 Remote Response - Specimen receptacle IVDs
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Intended Purpose

Microbial nucleic acid storage and stabilization device. PrimeStore MTM is a microbial nucleic acid storage and stabilization device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
May 31, 2020
Effective Date
May 31, 2020
Manufacturer
Country
United States of America
Address
Bethesda Metro Center Suite 910, Bethesda, Maryland, 20814