Zymo Research’s COVID-19 Sample Collection Device Cleared by FDA

The FDA has granted 510(k) clearance for Zymo Research’s DNA/RNA Shield Collection Tube, an in vitro diagnostic that safely collects SARS-CoV-2 RNA samples for transport.

Zymo said that the device is the first one cleared by the FDA that can store RNA samples while inactivating the virus, a feature that improves safety for frontline healthcare workers and laboratory staff.

The viral RNA placed in the device is stabilized at an ambient temperature for up to 28 days for evaluation by reverse transcription polymerase chain reaction (RT-PCR).