Australia TGA ARTG record

Specimen receptacle IVDs

Australia TGA ARTG Registered Device · Kirby Institute - COVID-19 Remote Response · Longhorn Vaccines and Diagnostics LLC · Class I · Started May 31, 2020

Good Name: Kirby Institute - COVID-19 Remote Response - Specimen receptacle IVDs

Device classification

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

Registration information

Start Date: May 31, 2020
Effective Date: May 31, 2020

Sponsor

Name: Kirby Institute - COVID-19 Remote Response

Manufacturer

Name: Longhorn Vaccines and Diagnostics LLC
Country: United States of America
Address: Bethesda Metro Center Suite 910, Bethesda, Maryland, 20814

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.

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 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.