Australia TGA ARTG record

Bacterial infectious disease IVDs

Australia TGA ARTG Registered Device · National Serology Reference Laboratory · Exact Diagnostics LLC · Class IIa · Started September 28, 2017

Good Name: National Serology Reference Laboratory - Bacterial infectious disease IVDs

Device classification

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

Registration information

Start Date: September 28, 2017
Effective Date: September 28, 2017

Sponsor

Name: National Serology Reference Laboratory

Manufacturer

Name: Exact Diagnostics LLC
Country: United States of America
Address: 3400 Camp Bowie Blvd, Fort Worth, TX, CBH-214

Intended purpose

Non assay-specific viral infectious disease quality control material intended to detect bacterial nucleic acids in human serum, plasma or other samples of human origin.

About this record

Access comprehensive regulatory information for Bacterial infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by National Serology Reference Laboratory, manufactured by Exact Diagnostics LLC in United States of America. The device registration started on September 28, 2017.

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.