Oragene Dx

Basic Information

• Brand Name: Oragene Dx
• Primary DI: 00627595000019
• Version / Model: OGD-500
• Company Name: DNA Genotek Inc
• Labeler DUNS: 207983508
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 9
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: fccd9c43-6588-43bc-b589-07dfd5874537

Device Description

DNA Specimen Collection, Saliva

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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
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
62392	Oral/respiratory tract specimen container IVD, additive/medium	A covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00627595000019	GS1
Package	00627595000736	GS1	OGD-500.002	1	In Commercial Distribution
Package	00627595000897	GS1	OGD-500.017	1	In Commercial Distribution
Package	10627595000900	GS1	OGD-500.017+ACP095	1	In Commercial Distribution
Package	10627595000962	GS1	SOF-8013	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110701	000
K192920	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius