Company · CA
DNA Genotek, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (1 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OYJ | Dna Specimen Collection, Saliva | 7 |
| PPM | General Purpose Reagent | 1 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 1 |
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | 1 |
| SIH | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2026 | K254121 | Colli-PeeDx Urine Collection Kit DNA Genotek, Inc., CA | SIH |
| Oct 27, 2022 | K212745 | ORAcollect®Dx DNA Genotek, Inc., CA | OYJ |
| Nov 3, 2021 | DEN200040 | OMNIgene GUT Dx DNA Genotek, Inc., CA | QPO |
| Jan 14, 2020 | K192920 | Oragene®Dx DNA Genotek, Inc., CA | OYJ |
| May 26, 2016 | K152556 | Oragene Dx DNA Genotek, Inc., CA | OYJ |
| May 26, 2016 | K152464 | ORAcollect.Dx DNA Genotek, Inc., CA | OYJ |
| Feb 19, 2015 | K141410 | ORAGENE DX OGD-500.001 DNA Genotek, Inc., CA | OYJ |
| Dec 2, 2011 | K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 DNA Genotek, Inc., CA | OYJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2022 | DNA Genotek Inc. ORAcollect RNA: ORE-100 Open, Classified |
QJR | None listed |
| Feb 18, 2022 | DNA Genotek Inc. 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.02 Open, Classified |
OYJ | K152464 |
| Jun 24, 2020 | DNA Genotek Inc. 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 usin Terminated |
PPM | None listed |