FDAnews
www.fdanews.com/articles/208113-nanomix-receives-a-ce-mark-for-its-elab-covid-19-rapid-point-of-care-antigen-panel

Nanomix Receives a CE Mark for Its eLab COVID-19 Rapid Point-of-Care Antigen Panel

June 7, 2022

Emeryville, Calif.-based Nanomix has received a CE mark for its eLab COVID-19 rapid antigen test, which delivers results in 15 minutes.

The nasal swab samples are collected using a sample collection tube and then transferred to a single-use cartridge that is processed in the company’s eLab analyzer.

The portable eLab system is a hand-held immunoassay and chemistry diagnostic device that provides “results comparable in quality to those provided by central lab testing,” the company said. The results can be printed or sent electronically via Bluetooth. The system can also output the results as a QR code.

Nanomix, which specializes in point-of-care diagnostics, is also developing other rapid tests to make high-quality diagnostic information available within minutes.

View today's stories