Oragene Dx

Basic Information

• Brand Name: Oragene Dx
• Primary DI: 00627595000248
• Version / Model: OGD-600
• Company Name: DNA Genotek Inc
• Labeler DUNS: 207983508
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 8
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 85d02c04-e38d-40f3-b36e-802c1ee338ca

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	00627595000248	GS1
Package	00627595000095	GS1	OGD-600.018	1	In Commercial Distribution
Package	00627595000323	GS1	OGD-600.018+ACP088	1	In Commercial Distribution
Package	10627595000979	GS1	SOF-1003	1	In Commercial Distribution
Package	10627595000801	GS1	SOF-1014	1	In Commercial Distribution
Package	10627595001310	GS1	SOF-1016	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152556	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