Test For Periprosthetic Joint Infection

PIL · Not classified · Unknown

Classification

FDA Product Code: PIL
Device class: Not classified
Regulation: —
Review panel: IM
Medical specialty: Unknown
Submission type: 3
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown