ARTG 474587

Specimen receptacle IVDs

ARTG ID: 474587 · Abacus dx Pty Ltd · Longhorn Vaccines and Diagnostics LLC · Class I · Started December 23, 2024

Good Name: Abacus dx Pty Ltd - Specimen receptacle IVDs

Device classification

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

Registration information

ARTG ID: 474587
Start Date: December 23, 2024
Effective Date: December 23, 2024

Sponsor

Name: Abacus dx Pty Ltd

Manufacturer

Name: Longhorn Vaccines and Diagnostics LLC
Country: United States of America
Address: 7272 Wisconsin Avenue 9th Floor, Bethesda, MD, 20814

Intended purpose

Prime Store Molecular Transport Medium (PS-MTM) is intended for inactivation of infectious samples and stabilization and transportation of microbial RNA and DNA.

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 registered under ARTG number 474587 and sponsored by Abacus dx Pty Ltd, manufactured by Longhorn Vaccines and Diagnostics LLC in United States of America. The device registration started on December 23, 2024.

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.