Oragene Dx

Basic Information

• Brand Name: Oragene Dx
• Primary DI: 00627595000286
• Version / Model: OYD-500
• Company Name: DNA Genotek Inc
• Labeler DUNS: 207983508
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-08
• Public Version: 1
• Public Version Date: 2025-09-16
• Public Version Status: New
• Public Device Record Key: 5633c5a8-ae41-4354-a1ec-497c660f58f6
• Distribution End Date: 2025-09-08

Device Description

DNA Specimen Collection, Saliva

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60889	Specimen mailer kit	A collection of items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form, and a specimen container mailer. This is a single-use device.	No	Obsolete
61935	Specimen stabilization reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs to prevent degradation of sensitive analytes (e.g., hormones, proteins, peptides and/or nucleic acids) in a clinical specimen during transportation, storage or processing. A stabilizer is typically a solvent, antioxidant or an enzyme inhibitor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00627595000286	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K110701	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius