Device Dossier
Photopheresis system blood set
Device Dossier for Photopheresis system blood set (Photopheresis system blood set, Class IIa, sponsor Therakos). ARTG record, intended purpose, GMDN…
- GMDN category: Photopheresis system blood set
- Sponsor: Therakos
Intended purpose
The THERAKOS™ CELLEX™ Photopheresis Procedural Kits are indicated to be used as part of the THERAKOS™ CELLEX™ Photopheresis System: For patients older than 18 years of age for the administration of photopheresis in the following: Cutaneous T Cell Lymphoma (CTCL) Solid Organ Transplant Rejection (SOT) (heart, lung) and For patients older than 3 years of age for the management of Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD).