Cotinine ELISA EIA-5917

GUDID 00840239059178

The Cotinine ELISA Kit is intended for the measurement of Cotinine in serum, urine.

DRG International Inc

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239059178
• NIH Device Record Key: 5760b732-05ed-46ee-bf54-b44b606d0eb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cotinine ELISA
• Version Model Number: EIA-5917
• Catalog Number: EIA-5917
• Company DUNS: 075150847
• Company Name: DRG International Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(973)564-7555
• Email: corp@drg-international.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239059178 [Primary]

FDA Product Code

• MRS: Test system, nicotine, cotinine, metabolites

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-30
• Device Publish Date: 2019-06-10

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