The plan focuses on five scientific priorities to advance research and development over the next five years, including developing diagnostic tests for the diseases.
In US influenza testing, providers see growth in placements within hospital emergency departments, physicians' offices, urgent care centers, and retail clinics.
Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.
The test, cleared for use with Quidel’s Triage MeterPro instrument, uses monoclonal antibodies that are specific for the metabolites of nine drug classes.
Some at-home infectious disease tests and sample collection kits exist in a murky regulatory realm, and their sale to patients is troubling laboratorians and clinicians.
