| Primary Device ID | 00627595000019 |
| NIH Device Record Key | fccd9c43-6588-43bc-b589-07dfd5874537 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oragene Dx |
| Version Model Number | OGD-500 |
| 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 | false |
| 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 | |
| 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 | |
| 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 | |
| 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 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627595000019 [Primary] |
| GS1 | 00627595000736 [Package] Package: OGD-500.002 [1 Units] In Commercial Distribution |
| GS1 | 00627595000897 [Package] Package: OGD-500.017 [1 Units] In Commercial Distribution |
| GS1 | 10627595000900 [Package] Contains: 00627595000897 Package: OGD-500.017+ACP095 [1 Units] In Commercial Distribution |
| GS1 | 10627595000962 [Package] Package: SOF-8013 [1 Units] In Commercial Distribution |
| OYJ | Dna Specimen Collection, Saliva |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-08 |
| 00627595000262 | DNA Specimen Collection, Saliva (For Assisted Collection) |
| 00627595000255 | DNA Specimen Collection, Saliva |
| 00627595000248 | DNA Specimen Collection, Saliva |
| 00627595000224 | DNA Specimen Collection, Saliva (For assisted collection) |
| 00627595000132 | DNA Specimen Collection, Saliva |
| 00627595000026 | DNA Specimen Collection, Saliva (For Over-the-Counter Use) |
| 00627595000019 | DNA Specimen Collection, Saliva |