510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QPOClass II

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

21 CFR 866.2952 / Microbiology
FDA source (opens on fda.gov)

QPO is the FDA product code for Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples, a class II device type, regulated under 21 CFR 866.2952. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 6 recalls.

Classification record

Product code
QPO
Device name
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
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.
Regulation
21 CFR 866.2952
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
6

Clearances, product code QPO

By decision year
1 clearance under product code QPO with a decision year between 2021 and 2021, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QPO by decision year
YearClearances
20211

Applicants with the most clearances

Product code QPO
Applicants holding the most 510(k) clearances under product code QPO
ApplicantClearances
DNA Genotek Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code