ORAcollect Dx

Basic Information

• Brand Name: ORAcollect Dx
• Primary DI: 00627595000309
• Version / Model: OCD-100
• Company Name: DNA Genotek Inc
• Labeler DUNS: 207983508
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 10
• Public Version Date: 2024-08-13
• Public Version Status: Update
• Public Device Record Key: 4f3538d2-4ec0-427c-bbc9-39172bff38e2

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
Primary	00627595000309	GS1
Package	10627595000306	GS1	Reclosable Bag	25	In Commercial Distribution
Package	00627595001108	GS1	OCD-100.008	1	In Commercial Distribution
Package	10627595001112	GS1	OCD-100.008+ACP096	25	In Commercial Distribution
Package	10627595000078	GS1	OCD-100+ACP041	10	In Commercial Distribution
Package	00627595000040	GS1	OCD-100.032	1	In Commercial Distribution
Package	10627595000047	GS1	OCD-100.032 Reclobag	25	In Commercial Distribution
Package	00627595000163	GS1	OCD-100.032+ACP103	25	In Commercial Distribution
Package	00627595001085	GS1	OCD-100.033	1	In Commercial Distribution
Package	00627595000057	GS1	OCD-100.034	1	In Commercial Distribution
Package	00627595000170	GS1	OCD-100.034+ACP099	25	In Commercial Distribution
Package	10627595000955	GS1	OCD-100+ACP127	25	In Commercial Distribution
Package	10627595000863	GS1	OCD-100+ACP126	1	In Commercial Distribution
Package	00627595000835	GS1	OCD-100.035	1	In Commercial Distribution
Package	10627595000832	GS1	OCD-100.035+ACP140	10	In Commercial Distribution
Package	10627595001327	GS1	OCD-100+ACP125	25	Not in Commercial Distribution	2024-01-01
Package	10627595000856	GS1	SOF-1015	1	In Commercial Distribution
Package	10627595001365	GS1	SOF-1017	1	Not in Commercial Distribution	2023-12-01
Package	10627595000993	GS1	SOF-4814	1	In Commercial Distribution
Package	10627595001372	GS1	SOF-1018	1	Not in Commercial Distribution	2024-01-01
Package	10627595001099	GS1	SOF-1011	1	In Commercial Distribution
Package	00627595001146	GS1	OCD-100.037	1	In Commercial Distribution
Package	10627595001150	GS1	OCD-100.037+ACP152	25	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius