Zymo Research Receives 510(k) Clearance for its Collection/Transport Device for COVID-19
The first 510(k)-cleared transport medium for COVID-19 testing Zymo Research announced today the U.S. Food and Drug Administration (FDA) has cleared its DNA/RNA Shield™ Collection Tube as a Class II medical device. The FDA’s 510(k) clearance allows the product to be used as an In-vitro Diagnostic (IVD) device for COVID-19 testing. Specifically granted for COVID-19 […]