6 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable
FDA Enforcement
Class II
·Ongoing·THERAKOS DEVELOPMENT LIMITED·April 22, 2026
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
FDA Enforcement
Class II
·Ongoing·Cellex·September 22, 2021
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
FDA Enforcement
Class II
·Ongoing·Mallinckrodt Pharmaceuticals Ireland Ltd·February 16, 2022
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
FDA Enforcement
Class II
·Ongoing·Therakos, Inc.·November 17, 2021
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
FDA Enforcement
Class II
·Ongoing·Ellex Medical Pty Ltd.·July 5, 2023
Alinity hq Analyzer, REF: 09P68-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 28, 2024