FDA clears new indications for existing Lyme disease tests

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“These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.

The FDA granted 510(k) clearance of the tests to Zeus Scientific.