FDA clears Nova’s Stat Profile Prime Plus analyzer for micro capillary sample mode
Oct. 4, 2023
Nova Biomedical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a micro capillary sample mode on the Stat Profile Prime Plus Critical Care analyzer.
Prime Plus now performs an 11-test panel including pH, PCO2, PO2, Na, K, iCa, iMg, Cl, glucose, lactate, and hematocrit with just 90 microliters of capillary blood, or a complete 22-test profile on just 135 microliters of blood. The micro capillary sampling mode adds to Prime Plus blood conservation capabilities for critical care diagnostic testing and is available as a standard feature on all Prime Plus analyzers.
