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U.S. Department of Health and Human Services

Product Classification
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Device test for periprosthetic joint infection
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.
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
Product CodePIL
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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