2 results
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis
FDA Enforcement
Class II
·Terminated·Therakos Inc·April 13, 2016
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
FDA Enforcement
Class II
·Ongoing·Therakos, Inc.·November 17, 2021