FDA clears Nova Prime Plus for microcapillary sample mode

Oct. 5, 2023—Nova Biomedical announced that the FDA has granted 510(k) clearance for a microcapillary sample mode on the company’s Stat Profile Prime Plus critical care blood gas analyzer. It is available as a standard feature.

Prime Plus performs an 11-test panel that includes pH, PCO2, PO2, Na, K, iCa, iMg, Cl, glucose, lactate, and hematocrit using 90 μL of capillary blood or a complete 22-test profile using 135 μL of blood.