Nano-CheckTM Nicotine

Basic Information

• Brand Name: Nano-CheckTM Nicotine
• Primary DI: 00895160002359
• Version / Model: AD6083
• Catalog Number: AD6083
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 793833f7-b362-4dea-a4bc-bf0ba44eae1d

Device Description

In Vitro Diagnostic Test kit for the detection of Cotinine in human urine

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	862.3220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55582	Cotinine (nicotine metabolite) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cotinine (nicotine metabolite) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00895160002359	GS1
Unit of Use	10895160002356	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius