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Severe acute respiratory syndrome-associated coronavirus IVDs

Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Bio-Rad Laboratories Pty Ltd, manufactured by Bio-Rad in France. The device registration started on June 22, 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.

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TGA ARTG Official Data
Class IIb
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device
Good Name: Bio-Rad Laboratories Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
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DJ Fang

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Intended Purpose

IVDs that are intended to be used in testing to provide information about infection with or exposure to Severe acute respiratory sydrome-associated coronavirus (SARSCoV).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
June 22, 2020
Effective Date
January 30, 2023
Manufacturer
Country
France
Address
3 Boulevard Raymond Poincare, 92430 MARNES-LA-COQUETTE