HalioDx has all of the technology platforms necessary for its operations: immunohistochemistry, digital pathology, high throughput next generation sequencing, single cell, quantitative PCR and nCounter® technology (Nanostring).
HalioDx is certified ISO 13485 (since 2007) as well as ISO 9001 (since 2012).
For Europe, the Quality Management System is also maintained to meet the Medical Device Directive 98/79/EC.
For FDA registration, products are developed, manufactured and controlled as requested by the USA regulation and following cGMP requirements for medical devices.
CLIA for California n° COS 00800828
CLIA for Maryland n° 2730
CLIA for Pennsylvania n° 35816