ARTG 341959Infectious disease IVDs
ARTG ID: 341959 · Abbott Rapid Diagnostics Pty Ltd · Abbott Rapid Diagnostics Jena GmbH · Class I · Started August 21, 2020
Good Name: Abbott Rapid Diagnostics Pty Ltd - Infectious disease IVDs
- Risk Class
- Class I
- Product Type
- IVD
- ARTG Category
- IVD-Export
- ARTG ID
- 341959
- Start Date
- August 21, 2020
- Effective Date
- August 21, 2020
- Country
- Germany
- Address
- Orlaweg 1, Jena, Germany, 07743
Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. Panbio™ COVID-19 Ag Rapid Test Device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don't preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a donor screening test for SARS-CoV-2.
Access comprehensive regulatory information for Infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 341959 and sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Rapid Diagnostics Jena GmbH in Germany. The device registration started on August 21, 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.