FDA Registration
Active
🇨🇦 Canada
DNA GENOTEK, INC.
Reg #: 3003742580
·
FEI: 3003742580
·
Expires 2026
Products
10
Proprietary Names
40
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- DNA GENOTEK, INC.
- Registration Number
- 3003742580
- FEI Number
- 3003742580
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3000 - 500 Palladium Drive
- City
- Ottawa Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K152556
Owner / Operator
- Firm Name
- DNA GENOTEK, INC.
- Operator Number
- 9054962
- Address
- 3000 - 500 Palladium Drive
- City
- Ottawa
- State
- Ontario
- Postal Code
- K2V 1C2
- Country
- CA
US Agent
- Business Name
- ORASURE TECHNOLOGIES INC.
- Contact Name
- Tiffany Miller
- Address
- OraSure Technologies, Inc., 220 East First Street
- City
- Bethlehem
- State
- PA
- ZIP
- 18015
- Country
- US
- [email protected]
- Phone
- 610 8821820 ext. 3014
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dna Specimen Collection, Saliva | OYJ | Class 2 | Clinical Chemistry | No | 2016-06-20 |
| Research Use Only/Microbiology | OTT | Class N | Unknown | No | 2012-01-27 |
| Research Use Only/Clinical Chemistry Devices | OTV | Class N | Unknown | No | 2012-01-27 |
| Research Use Only/Hematology Devices | OTQ | Class N | Unknown | No | 2015-01-23 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2007-11-12 |
| Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | QPO | Class 2 | Microbiology | No | 2021-11-18 |
| SIH | No | 2026-06-11 | |||
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2020-10-26 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2011-03-16 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2011-03-16 |
Proprietary Names
Oragene Dx (OGD-510, OGD-600, OGD-610, OGD-675)
OMNIgene ORAL (OM-501, OMR-110, OMR-120)
OMNIgene GUT (OMR-200)
OMNIgene VAGINAL (OMR-130)
OMNIgene SKIN (OMR-140)
OMNImet GUT (OME-200)
OMNIgene GUT DNA & RNA (OMR-205)
N00345_RUO Colli-Pee UAS FV-5010-RUO
N00260_RUO Colli-Pee UCM FV-5004-RUO
N00342_RUO Colli-Pee UAS FV-5040-RUO
N00339_PROTO Colli-Pee UAS FV-5020-PROTO
N00327_RUO Colli-Pee UCM FV-5010-RUO
N00269_RUO Colli-Pee Large Volumes RUO
N00290_RUO Colli-Pee 4 mL RUO
N00176_RUO Colli-Pee UCM FV-5020-RUO
ORAcollect Dx (OCD-100, OCD-100A)
Oragene RNA (RE-100)
ORAcollect for Pediatrics (OC-175)
HEMAgene BUFFY COAT (HG-BCD-50, HG-BCD-250)
Colli-Pee FV-5040 Urine Collection Container
Colli-Pee UCM FV-5003b Urine Collection Container
Colli-Pee UCM FV-5004 Urine Collection Container
Colli-Pee UCM FV-5010 Urine Collection Container
Colli-Pee FV-5010 Urine Collection Container
Colli-Pee FV-5004 Urine Collection Container
Colli-Pee FV-5020c Urine Collection Container
Colli-Pee UCM FV-5020 Urine Collection Container
Colli-Pee FV-5020 Urine Collection Container
Colli-Pee UAS FV-5040 Urine Collection Container
OMNIgene GUT Dx OMD 200
Colli-PeeDx Urine Collection Kit
OMNIgene ORAL (OM-505; OME-505)
ORAcollect RNA (ORE-100)
Oragene Dx (OGD-500, OGD-575)
Oragene Dx (OGD-50001)
Accessories, sample collection: OG-AC1
Oragene Dx (OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675)
PrepIT Q2A (PT-Q2A-96, PT-Q2A-384)
OMNIgene Liquefaction Reagent (OM-LQR-400, OM-LQR-1600)
PrepIT L2P (PT-L2P-5, PT-L2P-45)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)