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Bacterial infectious disease IVDs - ARTG 302402

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 registered under ARTG number 302402 and sponsored by Australian Rickettsial Reference Laboratory Foundation Ltd, manufactured by Fuller Laboratories in United States of America. The device registration started on April 28, 2018.

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
ARTG 302402
Class IIa
Bacterial infectious disease IVDs
ARTG ID: 302402
Good Name: Australian Rickettsial Reference Laboratory Foundation Ltd - Bacterial infectious disease IVDs
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Intended Purpose

IVDs designed for the detection and semiquantitation of antibodies against Borrelia in human serum or plasma. Laboratory test only.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
302402
Start Date
April 28, 2018
Effective Date
April 28, 2018
Manufacturer
Country
United States of America
Address
1312 E Valencia Drive, Fullerton, CA, 92831