Product Classification

• Device: multiple osteoarticular pathogen antigen kit
• Definition: Qualitative detection of microbial antigen in synovial fluid
• Physical State: Reaction of the microbial antigen present in the sample with a genera-specific anti-microbial polyclonal antibody
• Technical Method: Immunometric multiplexed assay run on a fluorescent immunoassay instrument
• Target Area: Synovial fluid
• Review Panel: Microbiology
• Product Code: QHV
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• 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