NEW YORK — Zymo Research said on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its DNA/RNA Shield SafeCollect Saliva Collection Kit for use in COVID-19 molecular testing.
According to Zymo, the kit is now cleared as a Class II medical device for microbial nucleic acid storage and stabilization, allowing it to be used as an in vitro diagnostic device for saliva collection and transport. It includes the Irvine, California-based company's DNA/RNA Shield preservation reagent.
The clearance was specifically granted for COVID-19 testing, Zymo noted.
About two years ago, Zymo received CE marking for its SafeCollect line of saliva and swab sample collection kits.