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U.S. Department of Health and Human Services

Product Classification

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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 CodeQHV
Premarket Review Division of Microbiology Devices (DMD)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible