Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Abbott Rapid Diagnostics Pty Ltd · Abbott Rapid Diagnostics Jena GmbH · Class IIb · Started September 30, 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
- Start Date
- September 30, 2020
- Effective Date
- September 12, 2023
- Country
- Germany
- Address
- Orlaweg 1, Jena, Germany, 07743
Intended to detect the novel coronavirus SARS-CoV-2 at the point of care by trained health professionals (nasopharyngeal and nasal swabs) from individuals who meet COVID-19 clinical and / or epidemiological criteria and for self-testing by lay persons (nasal swabs) to aid in the diagnosis of an active SARS-COV-2 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 sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Rapid Diagnostics Jena GmbH in Germany. The device registration started on September 30, 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.