PIL — Test For Periprosthetic Joint Infection Class N
FDA product code PIL covers "Test For Periprosthetic Joint Infection", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PIL
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Unknown
- Implant
- No
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.