Quidel Earns 510(k) Clearance for Triage TOX Drug Screen

June 21, 2019

Quidel Corporation received 510(k) clearance from the FDA for its  Triage TOX Drug Screen, 94600, a fluorescence immunoassay for detecting the presence of drug and/or metabolites in human urine of up to nine drug assays.

Results are typically displayed in approximately 15 minutes from the addition of specimen and are stored in the meter’s memory to display or print when needed. If connected, the Meter can transmit results to the laboratory or hospital information system.

The test is used with Quidel’s Triage MeterPro instrumented system. The  company is optimistic that the assay will boost its Triage sales and create  further growth for its  MeterPro instruments. “We believe that our latest diagnostic screening test can play an important role in providing fast, diagnostic answers to healthcare providers in the emergency and urgent care settings,” said Quidel’s CEO, Douglas Bryant.

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