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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples
Definition A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms.
Product CodeQPO
Regulation Number 866.2952
Device Class 2


Premarket Reviews
ManufacturerDecision
DNA GENOTEK INC.
  GRANTED 1

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