Cotinine (COT) Rapid Test Panel

Basic Information

• Brand Name: Cotinine (COT) Rapid Test Panel
• Primary DI: 06970277512527
• Version / Model: DCT-114
• Catalog Number: DCT-114
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Labeler DUNS: 543254717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2018-09-10
• Public Version: 1
• Public Version Date: 2018-10-11
• Public Version Status: New
• Public Device Record Key: adca989b-3b04-449f-a82d-4f8cb06e8871

Device Description

Cotinine (COT) Rapid Test Panel box of 40

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	862.3220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55579	Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cotinine (nicotine metabolite) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970277512527	GS1
Unit of Use	06970277512510	GS1