QPO

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Device class

Class II (moderate risk)

Regulation

21 CFR 866.2952

Medical specialty

Microbiology

FDA 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.

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