February 2019—Thermo Fisher Scientific received FDA clearance for its de novo submission of its QMS Plazomicin Immunoassay. This quantitative immunoassay measures the concentration of a novel therapeutic antibiotic, plazomicin, using the Beckman Coulter AU 680 automated clinical chemistry analyzer. Plazomicin (Zemdri, Achaogen) is a next-generation aminoglycoside being used to treat patients with complicated urinary tract infections.
The QMS Plazomicin Immunoassay, developed in collaboration with Achaogen, is the latest addition to the company’s line of therapeutic drug monitoring immunoassays.
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