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Bacterial infectious disease IVDs

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.

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Class IIa
Class IIa
Bacterial infectious disease IVDs
Australia TGA ARTG Registered Device
Good Name: National Serology Reference Laboratory - Bacterial infectious disease IVDs
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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.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
September 28, 2017
Effective Date
September 28, 2017
Manufacturer
Country
United States of America
Address
3400 Camp Bowie Blvd, Fort Worth, TX, CBH-214