This page includes the latest FDA filings for Dna Genotek Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3003742580 |
| FEI Number | 3003742580 |
| Name | Tiffany A Miller |
| Owner & Operator | DNA GENOTEK, INC. |
| Contact Address | 3000 - 500 Palladium Drive Ottawa CA-ON Ontario K2V 1C2 CA |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| DNA Genotek Inc | Oragene Dx | 2025-09-16 |
| DNA Genotek Inc | Oragene Dx | 2025-09-16 |
| DNA Genotek Inc | Colli-Pee N00342 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00260 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00383 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00327 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00176 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00269 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00290 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00238 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00309 | 2024-12-17 |
| DNA Genotek Inc | Colli-Pee N00055 | 2024-12-17 |
| DNA Genotek Inc | Accessory Sponges | 2022-11-29 |
| DNA Genotek Inc | OMNIgene ORAL | 2022-11-28 |
| DNA Genotek Inc | ORAcollect Dx | 2022-11-28 |
| DNA Genotek Inc | ORAcollect Dx | 2022-11-28 |
| DNA Genotek Inc | OMNIgene GUT Dx | 2022-11-28 |
| DNA Genotek Inc | OMNIgene Liquefaction Reagent | 2022-11-28 |
| DNA Genotek Inc | OMNIgene Liquefaction Reagent | 2022-11-28 |
| DNA Genotek Inc | PrepIT L2P PT-L2P-45 | 2022-11-28 |
| DNA Genotek Inc | PrepIT L2P PT-L2P-5 | 2022-11-28 |
DNA Genotek Inc | ORAcollect®•Dx | 2022-10-27 |
DNA Genotek Inc. | OMNIgene GUT Dx | 2021-11-03 |
DNA Genotek Inc. | Oragene®•Dx | 2020-01-14 |
| DNA Genotek Inc | ORAcollect Dx | 2018-07-06 |
| DNA Genotek Inc | Oragene Dx | 2018-07-06 |
| DNA Genotek Inc | Oragene Dx | 2018-07-06 |
| DNA Genotek Inc | Oragene Dx | 2018-07-06 |
| DNA Genotek Inc | Oragene Dx | 2018-07-06 |
| DNA Genotek Inc | Oragene Dx | 2018-07-06 |
| DNA Genotek Inc | Oragene Dx | 2018-07-06 |
| DNA Genotek Inc | Oragene Dx | 2018-07-06 |
Tiffany A Miller [DNA GENOTEK, INC.] | Oragene Dx (OGD-510, OGD-600, OGD-610, OGD-675) | 2016-06-20 |
Tiffany A Miller [DNA GENOTEK, INC.] | ORAcollect Dx (OCD-100, OCD-100A) | 2016-06-03 |
DNA Genotek Inc | Oragene Dx | 2016-05-26 |
DNA GENOTEK INC. | ORAcollect.Dx | 2016-05-26 |
Tiffany A Miller [DNA GENOTEK, INC.] | Oragene Dx (OGD-500.001) | 2015-03-03 |
DNA GENOTEK, INC. | ORAGENE DX OGD-500.001 | 2015-02-19 |
Tiffany A Miller [DNA GENOTEK, INC.] | HEMAgene BUFFY COAT (HG-BCD-50, HG-BCD-250) | 2015-01-23 |
Tiffany A Miller [DNA GENOTEK, INC.] | Oragene RNA (RE-100) | 2012-01-27 |
Tiffany A Miller [DNA GENOTEK, INC.] | Oragene DISCOVER (OGR-250, OGR-500, OGR-575) | 2012-01-27 |
Tiffany A Miller [DNA GENOTEK, INC.] | ORAcollect for Pediatrics (OC-175) | 2012-01-27 |
Tiffany A Miller [DNA GENOTEK, INC.] | OMNIgene VAGINAL (OMR-130) | 2012-01-27 |
Tiffany A Miller [DNA GENOTEK, INC.] | OMNIgene ORAL (OM-501, OM-505, OMR-110, OMR-120) | 2012-01-27 |
Tiffany A Miller [DNA GENOTEK, INC.] | OMNIgene GUT (OMR-200) | 2012-01-27 |
Tiffany A Miller [DNA GENOTEK, INC.] | Oragene Dx (OGD-500, OGD-575) | 2012-01-16 |
DNA GENOTEK INC | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | 2011-12-02 |
Tiffany A Miller [DNA GENOTEK, INC.] | PrepIT Q2A (PT-Q2A-96, PT-Q2A-384) | 2011-03-16 |
Tiffany A Miller [DNA GENOTEK, INC.] | PrepIT L2P (PT-L2P-1.5, PT-L2P-5, PT-L2P-45) | 2011-03-16 |
Tiffany A Miller [DNA GENOTEK, INC.] | OMNIgene SPUTUM (OM-SPD-50, OM-SPD-250, OM-SPD-1000) | 2011-03-16 |
Tiffany A Miller [DNA GENOTEK, INC.] | OMNIgene Liquefaction Reagent (OM-LQR-400, OM-LQR-1600) | 2011-03-16 |
Tiffany A Miller [DNA GENOTEK, INC.] | Accessories, sample collection: CS-1, CS-2, OG-AC1 | 2011-03-16 |
| NCAGE Code | L7044 | DNA GENOTEK INC |
| CAGE Code | L7044 | DNA GENOTEK INC |
| S.A.M. Registration | L7044 [207983508] | DNA GENOTEK INC |