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NEW YORK (360Dx) – TearLab today announced it has submitted a 510(k) application to the US Food and Drug Administration for its TearLab Discovery Platform, an in vitro diagnostic testing system for ophthalmic conditions.

The submission also covers a test card measuring the inflammatory biomarker MMP-9, TearLab said, adding the TearLab Discovery platform will be able to perform its current FDA-cleared tear osmolarity test.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.