| Primary Device ID | 10627595000825 |
| NIH Device Record Key | 7d5b9e85-da78-46a7-9e2b-2f88a1c068b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORAcollect Dx |
| Version Model Number | OCD-100.014 |
| Company DUNS | 207983508 |
| Company Name | DNA Genotek Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com | |
| Phone | 1-866-813-6354 |
| info@dnagenotek.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627595000712 [Primary] |
| GS1 | 10627595000641 [Package] Contains: 00627595000712 Package: SOF-1024 [1 Units] In Commercial Distribution |
| GS1 | 10627595000825 [Package] Contains: 00627595000712 Package: SOF-1004 [1 Units] In Commercial Distribution |
| GS1 | 10627595001341 [Package] Contains: 00627595000712 Package: OCD-100.014+ACP081 [25 Units] In Commercial Distribution |
| OYJ | Dna Specimen Collection, Saliva |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2022-11-18 |
| 00627595000309 | DNA Specimen Collection, Saliva |
| 10627595000825 | DNA Specimen Collection, Saliva |
| 10627595000313 | DNA Specimen Collection, Saliva |