Product code PDI

Device name

Beta 2-Microglobulin Apheresis Column

Medical specialty

Unknown

Device class

f

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset