MagBio Receives 510(k) Clearance and CE Mark for MagXtract Collection Tube
MagBio Genomics has received both 510(k) clearance from the FDA and CE mark approval from the European Union (EU) for its MagXtract Collection Tube.
The FDA clearance allows for use in COVID-19 testing in the U.S. while the CE mark allows the device to be marketed for testing for both COVID-19 and influenza in the EU.
It is also validated for bacterial and fungal sample collection and stabilization in research studies.
MagBio pointed out that the FDA advised laboratory staff at COVID-19 sample processing facilities to avoid collection devices that use guanidine-based mediums because when cleaned with bleach, it creates cyanide gas that is highly toxic and can also be fatal, said the company.
In response, the company created a tube that’s a guanidine-free molecular transport medium, making it the first guanidine-free molecular transport medium, FDA-cleared device available in the U.S. for COVID-19 testing.
MagBio says it has launched the device globally.