DNA Genotek Inc.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0982-2022 | Class II | ORAcollect RNA: ORE-100 | February 18, 2022 |
| Z-0981-2022 | Class II | ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD | February 18, 2022 |
| Z-3004-2020 | Class III | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) | June 24, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K212745 | ORAcollect®Dx | October 27, 2022 |
| DEN200040 | OMNIgene GUT Dx | November 3, 2021 |
| K192920 | Oragene®Dx | January 14, 2020 |
| K152556 | Oragene Dx | May 26, 2016 |
| K152464 | ORAcollect.Dx | May 26, 2016 |
| K141410 | ORAGENE DX OGD-500.001 | February 19, 2015 |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | December 2, 2011 |