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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lateral flow immunochromatography assay for host infection biomarkers
Definition A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.
Product CodeQGN
Regulation Number 866.3230
Device Class 2


Premarket Reviews
ManufacturerDecision
CD DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
CD DIAGNOSTICS INC.
  GRANTED 1

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