OMNIgene ORAL

GUDID 10627595001136

Nucleic Acids Specimen Collection and Stabilization, Saliva.

DNA Genotek Inc

Oral/respiratory tract specimen container IVD, additive/medium

• Primary Device ID: 10627595001136
• NIH Device Record Key: 0bf02061-1ee4-4641-8f3c-1a496f1b78a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNIgene ORAL
• Version Model Number: OME-505
• Company DUNS: 207983508
• Company Name: DNA Genotek Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627595000675 [Primary]
GS1	00627595000798 [Package]; Contains: 00627595000675; Package: OME-505.005 [1 Units]; In Commercial Distribution
GS1	10627595000795 [Package]; Contains: 00627595000798; Package: OME-505.005+ACP119 [1 Units]; In Commercial Distribution
GS1	10627595001136 [Package]; Contains: 00627595000675; Package: SOF-8010 [1 Units]; In Commercial Distribution

FDA Product Code

• LIO: Device, Specimen Collection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-28
• Device Publish Date: 2022-11-18

Devices Manufactured by DNA Genotek Inc

• 00627595000279 - Oragene Dx: 2025-09-16 DNA Specimen collection, Saliva
• 00627595000286 - Oragene Dx: 2025-09-16 DNA Specimen Collection, Saliva
• 00627595001627 - Colli-Pee: 2024-12-17 Urine Collection Container
• 00627595001634 - Colli-Pee: 2024-12-17 Urine Collection Container
• 00627595001641 - Colli-Pee: 2024-12-17 Urine Collection Container
• 00627595001658 - Colli-Pee: 2024-12-17 Urine Collection Container
• 00627595001665 - Colli-Pee: 2024-12-17 Urine Collection Container
• 00627595001672 - Colli-Pee: 2024-12-17 Urine Collection Container