510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200040Unknown

OMNIgene GUT Dx

DNA Genotek Inc., Ottawa, CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200040 is the FDA 510(k) clearance record for OMNIgene GUT Dx, a class II device, cleared for DNA Genotek, Inc. on under FDA product code QPO (Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples). FDA's definition for product code QPO 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...". FDA records list 8 510(k) clearances for DNA Genotek, Inc., from to . As of , FDA records show no recalls naming DEN200040.

Clearance record

Decision date
Received
(506 days to decision)
Product code
QPO Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
Regulation
21 CFR 866.2952
Device class
Class II
Review panel
Microbiology
Applicant
DNA Genotek, Inc. 3000 - 500 Palladium Dr., Ottawa, CA
Third party review
No

Clearances, product code QPO

Trailing 12 months

FDA records hold no clearances under product code QPO in the trailing twelve months.

FDA records show no clearances under product code QPO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QPO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260