Isohelix Files US FDA 510k Pre-Submission for GeneFix Saliva Collectors

Published: 09 January, 2023

Isohelix is pleased to announce that it has commenced engagement with the U.S. Food and Drug Administration (FDA) to progress the full regulatory approval of the GeneFix® Saliva DNA Collectors into the USA for their use in molecular and genetic diagnostics.

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GeneFix Saliva Collectors

The GFX DNA/RNA Saliva Collectors are easy to use, high quality devices for the collection and stabilization of saliva samples.

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