PILNot classified

Test For Periprosthetic Joint Infection

Unknown

PIL is the FDA product code for Test For Periprosthetic Joint Infection. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PIL
Device name: Test For Periprosthetic Joint Infection
FDA 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.
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

CD Diagnostics, Inc

Recent clearances

Product code PIL

FDA records hold no clearances under product code PIL.

Recent recalls

Product code PIL

FDA records show no recalls under product code PIL.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)