Issue Stories

Liquid-Stable Microalbumin Assay

Cleared by the FDA for human testing

 Diagnostic Chemicals Limited (DCL)’s two-part, liquid-stable Microalbumin assay has received 510(k) clearance from the US Food and Drug Administration (FDA) for the quantitative determination of the analyte in urine. The availability of this new assay will serve as a useful clinical tool in the diagnosis and treatment of diabetes and kidney disease. DCL’s Microalbumin assay employs an immunoturbidimetric test method, while offering exemplary performance characteristics with regard to accuracy, precision, and linearity. Optimized for use on a variety of instrument platforms, DCL’s Microalbumin assay is suited for use with fully automated testing procedures, with a variety of readily available applications. Offered in a compact packaging format, the test kit provides clinical laboratories with a configuration that is well suited for existing instrumentation and workflow requirements. Separate quality-control and calibration materials are also available to fully support the assay.

Diagnostic Chemicals Limited
(203) 881-2020; www.dclchem.com

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