BD FACS™ Loader, BD Multitest™ and BD Tritest™ products as intended on this page, BD Trucount™ Tubes, BD FACSPresto™ Near-Patient CD4 Counter, BD FACSPresto™ Cartridge, BD FACSCanto™ II Flow Cytometer and BD FACSLyric™ Flow Cytometer with the BD FACSuite™ Clinical and BD FACSuite™ applications are in vitro diagnostic medical devices bearing a CE mark.

BD Flow Cytometers are Class 1 Laser Products.  

BD FACSPresto™ Near-Patient CD4 Counter System is for point of care use.