Product code PIL

Device name

Test For Periprosthetic Joint Infection

Medical specialty

Unknown

Device class

N

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A qualitative in vitro diagnostic device intended as an adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid of patients experiencing pain and/or inflammation in a replacement joint.

Source

FDA openFDA device classification dataset