ARTG 345457Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 345457 · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc · Class IIb · Started October 06, 2020
Good Name: Abbott Rapid Diagnostics Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 345457
- Start Date
- October 06, 2020
- Effective Date
- December 21, 2023
- Country
- United States of America
- Address
- 10 Southgate Road, Scarborough, Maine, 04074
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.
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.