ORAcollect Dx

Basic Information

• Brand Name: ORAcollect Dx
• Primary DI: 00627595000316
• Version / Model: OCD-100A
• Company Name: DNA Genotek Inc
• Labeler DUNS: 207983508
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-18
• Public Version: 1
• Public Version Date: 2022-11-28
• Public Version Status: New
• Public Device Record Key: 60698651-346b-4865-ae1a-e65ebb8eea59

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
57940	Oral/upper respiratory tract specimen collection swab	A piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.	No	Active
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
Package	10627595000313	GS1	Reclosable Bag	25	In Commercial Distribution
Primary	00627595000316	GS1
Package	00627595001009	GS1	OCD-100A.022	1	In Commercial Distribution
Package	10627595001013	GS1	OCD-100A.022+ACP128	25	In Commercial Distribution
Package	00627595001023	GS1	OCD-100A.023	1	In Commercial Distribution
Package	10627595001037	GS1	OCD-100A.023+ACP129	25	In Commercial Distribution
Package	00627595001047	GS1	OCD-100A.024	1	In Commercial Distribution
Package	10627595001051	GS1	OCD-100A.024+ACP130	25	In Commercial Distribution
Package	00627595001061	GS1	OCD-100A.025	1	In Commercial Distribution
Package	10627595001075	GS1	OCD-100A.025+ACP131	25	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 68 – 78 Degrees Fahrenheit