FDA Grants 510(k) Clearance to the Diazyme Colorimetric Lithium Assay
30th Dec 2025
SAN DIEGO, CA - 30 December 2025 - Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearances to market the Diazyme Colorimetric Lithium Assay.
Diazyme Colorimetric Lithium Assay kit is for quantitative in vitro determination of lithium in human serum or EDTA plasma. Measurements of Lithium are carried out to ensure that proper drug do
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Next-Generation Lithium Testing: Diazyme’s Colorimetric Assay
Posted by Dr. Yuqi Huang, Assay Development Scientist at Diazyme Laboratories on 25th Jun 2025
Diazyme’s committed to innovations in clinical diagnostics. We are proud to spotlight Lead Scientist Dr. Yuqi Huang’s abstract presentation at ADLM 2025, showcasing the research behind our newly enhanced colorimetric lithium assay. Diazyme has submitted the newly developed assay for FDA’s review.
Dr. Huang’s poster highlights the importance of high precision testing i
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FDA Grants Diazyme 510(k) Clearance to Market Its Procalcitonin Assay for Clinical Chemistry Analyzers
25th Apr 2017
SAN DIEGO, CA – 25 April 2017 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Procalcitonin (PCT) assay. Procalcitonin, a propeptide synthesized in the C-cells of the thyroid, has been identified to be more clinically useful and superior than currently used common clinical variables and laboratory
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