FDA Grants Diazyme 510(k) Clearance to Market Its New EZ Vitamin D Assay for Clinical Chemistry Analyzers
22nd Jan 2018
SAN DIEGO, CA – 22 January 2018 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its EZ Vitamin D assay for Clinical Chemistry Analyzers. Diazyme's two reagent EZ Vitamin D assay provides the only fully automated two reagent Vitamin D test for use on validated clinical chemistry analyzers. .
"Diazyme's EZ Vitamin
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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 tests in th
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