co-innovation

Basic Information

• Brand Name: co-innovation
• Primary DI: 06970429843417
• Version / Model: COT TEST
• Company Name: Co-Innovation Biotech Co., Ltd
• Labeler DUNS: 421302978
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-19
• Public Version: 1
• Public Version Date: 2025-05-27
• Public Version Status: New
• Public Device Record Key: da73fb1b-a451-4a40-90a2-085325b0b01c
• Distribution End Date: 2025-05-19

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
64155	Cotinine IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of cotinine (nicotine metabolite) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the differentiation of smokers and non-smokers, or in the investigation of the link between smoking and associated disorders (e.g., cancer, coronary heart disease, stroke). It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16970429843414	GS1		20	Not in Commercial Distribution	2025-05-19
Primary	06970429843417	GS1
Package	26970429843411	GS1		25	Not in Commercial Distribution	2025-05-19
Package	36970429843418	GS1		50	Not in Commercial Distribution	2025-05-19
Package	46970429843415	GS1		100	Not in Commercial Distribution	2025-05-19