GROVE CITY, Ohio, Oct. 30, 2025 /PRNewswire/ -- Tosoh Bioscience, Inc., a market leader in clinical diagnostics has received U.S. FDA 510(k) clearance for its next-generation Tosoh Automated Glycohemoglobin Analyzer HLC®-723 GR01 (GR01) for HbA1c testing.
The GR01 Analyzer is designed for both diabetes diagnosis, identifying those at risk of developing diabetes, and long-term glucose monitoring, offering fast, precise, and reliable HbA1c results in just 50 seconds. Using Tosoh's proprietary non-porous ion-exchange HPLC technology, the GR01 delivers consistent accuracy and variant detection in every sample — supporting clinical confidence across diverse patient populations.
High-Speed Precision for Modern Laboratories
Compact yet powerful, the GR01 meets the needs of mid- to high-volume laboratories. It offers the throughput of a high-capacity system with streamlined operation, automatic buffer changes, and walkaway functionality to maximize efficiency and reduce hands-on time. The analyzer's intuitive touchscreen interface and LIS connectivity simplify workflow integration.
Accuracy You Can Trust
Delivering CVs ≤ 1.1% (NGSP Units), the GR01 provides reproducibility and reliability — helping clinicians make confident diagnostic and therapeutic decisions in diabetes management.
"The GR01 represents Tosoh's next leap forward in HbA1c testing — combining speed, precision, and simplicity in one compact system," said Shunsuke Kinoshita, President, Tosoh Bioscience, Inc. "It reaffirms our commitment to advancing diagnostic solutions that support better patient outcomes."
To receive more information about the GR01 analyzer please visit:
lab.tosoh.com/gr01
For more information about Tosoh Bioscience, Inc. please visit our website:
About Tosoh Bioscience
Tosoh Bioscience, Inc. provides highly sophisticated diagnostic systems for immunoassay and HPLC testing to doctor's offices, hospitals and reference laboratories throughout the Americas. Based in Grove City, OH, Tosoh Bioscience, Inc. is a U.S. subsidiary of Tosoh Corporation which is headquartered in Tokyo, Japan, and is part of Tosoh Corporation's Bioscience Division under the Tosoh Bioscience global brand.
Contact: Priya Sivaraman, Ph.D., Senior Product Manager
Email: priya.sivaraman@tosoh.com
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SOURCE Tosoh Bioscience, Inc.
