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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodePVQ
Regulation Number 866.3316
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
  SUBSTANTIALLY EQUIVALENT 1

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