Cotinine direct (serum/urine) ELISA (96 well)

Basic Information

• Brand Name: Cotinine direct (serum/urine) ELISA (96 well)
• Primary DI: 00840239054968
• Version / Model: EIA-5496
• Catalog Number: EIA-5496
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 2
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: 27f800e6-29b6-4d75-ae02-048511e745d3
• Distribution End Date: 2021-09-14

Device Description

The Cotinine direct (Serum/Urine) ELISA is a specific and sensitive in-vitro test to detect the presence of Cotinine in serum and urine.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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	00840239054968	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius