NEW YORK — Zymo Research said on Thursday that it has received 510(k) clearance from the US Food and Drug Administration for its DNA/RNA Shield Collection Tube, allowing its use for SARS-CoV-2 testing.
According to Zymo, the product consists of a tube filled with proprietary transport medium that stabilizes SARS-CoV-2 RNA for up to 28 days at ambient temperatures. The tube may be kitted with a swab or sputum collection kit, the company said.
Last year, Irvine, California-based Zymo received CE-IVD marking for the DNA/RNA Shield Collection Tube, as well as two other sample collection devices.