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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rt-qpcr assay for mrna transcript immune biomarkers
Regulation Description Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
Definition A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.
Product CodePRE
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUNEXPRESS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INFLAMMATIX, INC.
  SUBSTANTIALLY EQUIVALENT 1

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