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Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 345457

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 registered under ARTG number 345457 and sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc in United States of America. The device registration started on October 06, 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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Class IIb
ARTG 345457
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 345457
Good Name: Abbott Rapid Diagnostics Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
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Intended Purpose

Assays intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
345457
Start Date
October 06, 2020
Effective Date
December 21, 2023
Manufacturer
Country
United States of America
Address
10 Southgate Road, Scarborough, Maine, 04074