Baebies Receives FDA 510(k) Clearance for G6PD Test on FINDER Platform
DURHAM, N.C., Nov. 9, 2022 /PRNewswire/ -- Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- DURHAM, N.C., Nov. 9, 2022 /PRNewswire/ -- Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- The test is run on the FINDER platform, which features a toaster-sized instrument and a disposable cartridge.
- Test results display G6PD enzyme activity in units per gram of hemoglobin and adjusted male median values.
- With G6PD as the first FDA-cleared test on our FINDER platform, we look forward to adding many additional types of tests to the versatile and multifunctional platform."