Tosoh Bioscience, Inc. announced that it has received US FDA 510(k) clearance for its next-generation system for HbA1c testing- the Tosoh Automated Glycohemoglobin Analyzer HLC723-GR01 (hereafter “GR01”).
The GR01 is intended for monitoring the long-term blood glucose control of individuals with diabetes, as an aid in the diagnosis of diabetes and to help identify those who may be at risk of developing the disease.
With a compact footprint, the GR01 is a fully automated analyzer that harnesses Tosoh’s proprietary non-porous ion exchange HPLC column technology to deliver precise, reproducible A1c results in just 50 seconds—while also detecting the most common hemoglobin variants.
The analyzer’s automatic buffer change feature keeps the lab running smoothly with no workflow delays.
The analyzer is designed for walkaway operation and user-friendly capabilities to help laboratories save time and labor. The GR01 has an intuitive user interface and seamless integration with a Laboratory Information System (LIS).
