Diazyme Expands Diabetic Portfolio with Beta-Hydroxybutyrate Assay
San Diego, CA (May 31, 2021) - Diazyme announced today the launch of the FDA 510(k) exempt Beta-Hydroxybutyrate (BHB) Assay for the quantitative determination of Beta-Hydroxybutyrate in human serum or plasma. Diazyme’s enzymatic BHB assay is a dual vial liquid stable reagent that is designed for use on clinical chemistry analyzers.
In diabetic patients, the measurement of BHB along with blood glucose is essential for the assessment of the severity of diabetic coma.1 It serves as a reliable guide for monitoring the progress of insulin therapy for diabetic ketoacidosis and for any patient presenting to the emergency room with documented hypoglycemia, acidosis, alcohol ingestion or an unexplained increase in the anion gap.
This is the latest addition to Diazyme’s diabetic portfolio which includes 510(k) cleared assays such as Glycated Serum Protein, 1,5-Anhydroglucitol, Direct Enzymatic HbA1c and more.
Diazyme Laboratories, Inc., a Life Science Affiliate of General Atomics, is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic test reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats. Diazyme is a cGMP and ISO 13485 certified medical device manufacturer. Information regarding Diazyme's technology and products can be found on its website at www.diazyme.com
For Further Information Contact:
Abhijit Datta, Ph.D.
1. Harano Y, Kosugi K, Hyosu T, Uno S, Ichikawa Y and Shigeta Y, Clin Chem Acta 134, 327 (1983).