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28/11/2016 - Calprest NG FDA 510k clearance

Calprest®NG: FDA 510k (k160447)

Eurospital is pleased to inform that on November 10, 2016, Calprest NG received FDA 510K clearance.

Calprest NG, the New Generation reference test for the quantitative determination of calprotectin in the stool, introduces new and significant advantages to the determination of calprotectin in the stool.

Calprest NG is presently the Elisa kit with the widest range of determination of calprotectin available on the market, as it allows to measure concentrations up to 3000 mg/Kg. This makes Calprest NG the reference test for screening, follow-up and therapy monitoring of patients affected by Inflammatory Bowel Diseases (IBD) and to differentiate patients affected by Intestinal Bowel Syndrome (IBS).

The innovative and unique features of Calprest NG (curve based on human recombinant calprotectin and use of a specific mixture of mono / polyclonal antibodies) make it the product of choice for the laboratory diagnosis of intestinal inflammation.

Currently, only products manufactured by Eurospital received the FDA 510k clearance. No other kit for the detection of calprotectin available on the European market did receive it.

 

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