Cotinine (COT) Rapid Test Panel DCT-114

GUDID 06970277512527

Cotinine (COT) Rapid Test Panel box of 40

Hangzhou AllTest Biotech Co., Ltd.

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

• Primary Device ID: 06970277512527
• NIH Device Record Key: adca989b-3b04-449f-a82d-4f8cb06e8871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cotinine (COT) Rapid Test Panel
• Version Model Number: DCT-114
• Catalog Number: DCT-114
• Company DUNS: 543254717
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Device Count: 40
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970277512510 [Unit of Use]
GS1	06970277512527 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-11
• Device Publish Date: 2018-09-10

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