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.
Flu test sales were the second-highest for a quarter in the firm's history but were still $17.4 million lower than the year-ago quarter due to a much less intense flu season.
Among the updates provided Wednesday, Quidel's CEO noted the firm's growing presence in point-of-care markets, while PerkinElmer discussed plans for its Vanadis test.
The firm expects Q4 revenues to be in the $132 million to $133 million range, up 15 to 16 percent from a year ago and consistent with the consensus Wall Street estimate.
Veracyte was the only company in the 360Dx Index whose stock price rose last month while NantHealth, NeoGenomics, and Accelerate Diagnostics saw sharp declines.
A lack of attractive targets, high valuations, and a more attractive IPO market contributed to a 45 percent year-over-year decline in M&A.
The test is the first quantitative test on the firm's flagship Sofia immunoassay platform.