QPO

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

Product code

QPO

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.2952

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).