Rheonix Gets 510(k) Clearance for Encompass MDx Workstation and Test Kit for STDs
The FDA has granted 510(k) clearance to Rheonix’s Encompass MDx Workstation along with its STI TriPlex assay and male urine collection kit for the detection of sexually transmitted infections.
The automated workstation is intended to simplify laboratory workflows and reduce the burden on laboratory technicians.
Since early in the coronavirus pandemic, it has been used in combination with the Rheonix COVID-19 MDx assay, which was authorized by the FDA for emergency use, to enable same-day COVID-19 testing by laboratories.
Rheonix founder and CEO Greg Galvin said the company is planning to add more multiplexed tests to the platform.