News & Media

  • Diazyme Receives 510(K) FDA Clearance for Enzymatic Lithium Assay Kit

    SAN DIEGO, CA – December 23, 2003 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology® (STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market their Enzymatic Lithium Assay Kit for the quantitative in vitro determination of lithium in human serum.With Diazyme's Enzymatic Lithium Assay, serum...

  • Diazyme Receives 510(K) FDA Clearance for Homocysteine Assay Kit

    SAN DIEGO, CA - Sept. 3, 2003 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology® (STE) to develop low cost and high quality diagnostic products for clinical and research uses, announced that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market the Homocysteine Microtiter Plate Assay Kit.Diazyme has developed a Microtiter Plate Assay Kit to determine plasma homocysteine levels based on the STE Technology®.

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