Oragene Dx

GUDID 00627595000286

DNA Specimen Collection, Saliva

DNA Genotek Inc

Specimen stabilization reagent IVD

• Primary Device ID: 00627595000286
• NIH Device Record Key: 5633c5a8-ae41-4354-a1ec-497c660f58f6
• Commercial Distribution Discontinuation: 2025-09-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Oragene Dx
• Version Model Number: OYD-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

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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627595000286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110701

FDA Product Code

• OYJ: Dna Specimen Collection, Saliva

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: 2025-09-16
• Device Publish Date: 2025-09-08

On-Brand Devices [Oragene Dx]

• 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
• 00627595000286: DNA Specimen Collection, Saliva
• 00627595000279: DNA Specimen collection, Saliva