DNA Genotek Inc.
Ottawa Ontario, CA
DNA GENOTEK, INC. appears in FDA device records in Ottawa Ontario, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for DNA Genotek Inc. between 2011 and 2026. The busiest year on record is 2016, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254121 | Colli-Pee•Dx Urine Collection Kit | SIH | Substantially Equivalent | |
| K212745 | ORAcollect®•Dx | OYJ | Substantially Equivalent | |
| DEN200040 | OMNIgene GUT Dx | QPO | Unknown | |
| K192920 | Oragene®•Dx | OYJ | Substantially Equivalent | |
| K152556 | Oragene Dx | OYJ | Substantially Equivalent | |
| K152464 | ORAcollect.Dx | OYJ | Substantially Equivalent | |
| K141410 | ORAGENE DX OGD-500.001 | OYJ | Substantially Equivalent | |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | OYJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003742580 | 3003742580 | DNA GENOTEK, INC. | 3000 - 500 Palladium Drive, Ottawa Ontario K2V 1C2 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXFApplicator, Absorbent Tipped, Non-Sterile
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- SIHDevice For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
- QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
- LIODevice, Specimen Collection
- OYJDna Specimen Collection, Saliva
- PPMGeneral Purpose Reagent
- OTVResearch Use Only/Clinical Chemistry Devices
- OTQResearch Use Only/Hematology Devices
- OTTResearch Use Only/Microbiology
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0982-2022 | ORAcollect RNA: ORE-100 | Evaporation of stabilizing liquid reducing shelf life. | Class II | Open, Classified | |
| Z-0981-2022 | 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-100A.025 | Evaporation of stabilizing liquid reducing shelf life. | Class II | Open, Classified | |
| Z-3004-2020 | 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 sample collection kits. | Reagents were shipped to customers after the Use by data indicated on its labeling. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain