Shield Diagnostics (UK) awarded 510(k) for Diastat kits:
This article was originally published in Clinica
Executive Summary
Shield Diagnostics (UK) has received 510(k) clearance from the US FDA for its anti-Tg and anti-TPO Diastat kits. Both kits use ELISA technology to detect antibodies in human plasma or serum. Total assay time is two hours and the common reagents are interchangeable so both thyroid tests can be performed on the same patient sample dilution, says Shield. All 19 of Shield's Diastat products are now registered with the FDA.