FDA grants EUA for saline and swab collection kit

April 22, 2021

Enzo Biochem announced that the U.S. Food and Drug Administration (FDA) approved the company’s proprietary AMPICOLECT Saline and Swab kit for distribution under emergency use authorization (EUA).

The sample collection kit can be used with PCR-based molecular diagnostic or antigen-based testing platforms, including Enzo’s GENFLEX Molecular System, that require the collection of upper respiratory specimens for COVID-19 testing.

Enzo’s sample collection kit represents an integral part of the company’s vertically integrated products and services to support needs throughout the entire workflow of clinical diagnostic testing. Enzo’s approach has involved the development of specimen collection, sample processing and testing reagents, automated instrumentation for sample preparation and testing, and the validation, scale-up of manufacturing and commercialization of these components.

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