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U.S. Department of Health and Human Services

Product Classification

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Device rickettsia spp. nucleic acid based detection assay
Definition An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.
Physical State In vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Rickettsia spp. nucleic acids in human clinical specimens.
Technical Method Qualitative in vitro diagnostic assay that detects and identifies Rickettsia spp. nucleic acids in human clinical specimens.
Target Area Clinical specimens from patients suspected of infection with Rickettsia spp.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePVQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3316
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible