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PDI — Beta 2-Microglobulin Apheresis Column Class f

FDA Device Classification

FDA product code PDI covers "Beta 2-Microglobulin Apheresis Column", a Class f medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code: PDI
Device Class: Class f
Regulation Number
Submission Type
Review Panel: GU
Medical Specialty: Unknown
Implant: No

Definition

Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA).