Data / Medical devices / Canada / Dna Genotek, Inc.
Dna Genotek, Inc.: FDA-registered device maker in Ottawa Ontario, Canada, 8 510(k) clearances
Dna Genotek, Inc. is registered with the FDA (registration 3003742580) in Ottawa Ontario, Canada. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 10, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003742580
- Address
- 3000 - 500 Palladium Drive, Ottawa Ontario, Canada, K2V 1C2
- Owner or operator
- DNA GENOTEK, INC. (9054962)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 12, 2007
- Registered through
- 2027
- Brand names listed
- Accessories, sample collection: OG-AC1, Colli-Pee FV-5004 Urine Collection Container, Colli-Pee FV-5010 Urine Collection Container, Colli-Pee FV-5020 Urine Collection Container, Colli-Pee FV-5020c Urine Collection Container, Colli-Pee FV-5040 Urine Collection Container, Colli-Pee UAS FV-5040 Urine Collection Container, Colli-Pee UCM FV-5003b Urine Collection Container and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer | accessdata.fda.gov |
| Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | SIH | 2 | Manufacturer | accessdata.fda.gov |
| Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | QPO | 2 | Manufacturer | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Manufacturer | accessdata.fda.gov |
| Dna Specimen Collection, Saliva | OYJ | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Research Use Only/Clinical Chemistry Devices | OTV | N | Manufacturer | accessdata.fda.gov |
| Research Use Only/Hematology Devices | OTQ | N | Manufacturer | accessdata.fda.gov |
| Research Use Only/Microbiology | OTT | N | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 10, 2026 | K254121 | Colli-PeeDx Urine Collection Kit | SIH | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| October 27, 2022 | K212745 | ORAcollect®Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| November 3, 2021 | DEN200040 | OMNIgene GUT Dx | QPO | Unknown | DNA Genotek, Inc. | accessdata.fda.gov |
| January 14, 2020 | K192920 | Oragene®Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| May 26, 2016 | K152556 | Oragene Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| May 26, 2016 | K152464 | ORAcollect.Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| February 19, 2015 | K141410 | ORAGENE DX OGD-500.001 | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| December 2, 2011 | K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 18, 2022 | 89831 | Class II | Ongoing | ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-1 | Evaporation of stabilizing liquid reducing shelf life. | accessdata.fda.gov |
| June 24, 2020 | 86279 | Class III | Terminated | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral s | Reagents were shipped to customers after the Use by data indicated on its labeling. | accessdata.fda.gov |
Compare with other makers
- All makers of Dna Specimen Collection, Saliva
- All makers of Research Use Only/Microbiology
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Device, Specimen Collection
- All makers of Applicator, Absorbent Tipped, Non-Sterile
Updated June 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.