Test For Periprosthetic Joint Infection
Device Code: 3143
Product Code(s):
PIL 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 Classification Information
| Device Type ID | 3143 |
| Device Name | Test For Periprosthetic Joint Infection |
| Physical State | Test |
| Technical Method | 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. |
| Target Area | In Vitro |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PIL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3143 |
| Device | Test For Periprosthetic Joint Infection |
| Product Code | PIL |
TPLC Last Update: 2019-04-02 20:24:31