Australia TGA ARTG recordGeneral laboratory reagent and consumables IVDs
Australia TGA ARTG Registered Device · Bio-Strategy Pty Ltd · BioEcho Life Science GmbH · Class IIa · Started August 17, 2022
Good Name: Bio-Strategy Pty Ltd - General laboratory reagent and consumables IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- August 17, 2022
- Effective Date
- August 17, 2022
- Country
- Germany
- Address
- Nattermannallee 1, Koln, 50829
The BioEcho EchoLUTION Viral RNA/DNA Swab Kit Plus is intended for the isolation of viral RNA and DNA (depending on the viral particle to be detected) from nasopharyngeal and genital swabs as well as stool samples. The excellent purity of the isolated viral nucleic acid isolated with the EchoLUTION Viral RNA/DNA Swab Kit Plus allows immediate use in downstream PCR assays. The EchoLUTION Viral RNA/DNA Swab Kit Plus is intended for research purposes and in vitro diagnostics (IVD) use in a professional laboratory environment.
Access comprehensive regulatory information for General laboratory reagent and consumables IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Bio-Strategy Pty Ltd, manufactured by BioEcho Life Science GmbH in Germany. The device registration started on August 17, 2022.
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.