CytoChip receives FDA clearance and first CLIA Waiver for CitoCBC

Feb. 27, 2025
The CLIA-waived CitoCBC expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics.

CytoChip announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and a CLIA Waiver for its CitoCBC, making it the first cartridge-based CBC test to achieve this milestone.

A recent study published in Nature by researchers from Harvard Medical School at Massachusetts General Hospital highlights the value of personalized CBC testing for the early intervention of common diseases.

CitoCBC is engineered for both ease of use and high performance. Its self-contained cartridge simplifies the testing process while delivering a state-of-the-art 5-Part Differential CBC with a turnaround time of eight minutes.

This product will launch first in the United States, followed by select European countries upon receiving CE Marking.

CytoChip release