Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · PerkinElmer · Wallac Oy · Class IIb · Started September 01, 2020
Good Name: PerkinElmer - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- September 01, 2020
- Effective Date
- January 30, 2023
- Name
- PerkinElmer
- Name
- Wallac Oy
- Country
- Finland
- Address
- Mustionkatu 6, Turku, FI-20750
The assays are intended for the qualitative detection of SARS-CoV-2 nucleic acids or antibodies as an aid in diagnosing patients suspected of COVID-19 or with an adaptive immune response to SARS-CoV2.
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 PerkinElmer, manufactured by Wallac Oy in Finland. The device registration started on September 01, 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.