FDA Product Code QPO: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
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.
Leading manufacturers include DNA Genotek, Inc..
FDA 510(k) Cleared Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples Devices (Product Code QPO)
About Product Code QPO - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QPO since 2021, with 0 receiving FDA clearance (average review time: 506 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
QPO devices are reviewed by the Microbiology panel. Browse all Microbiology devices →