Cotinine (COT) Rapid Test Dipstick DCT-101

GUDID 06970277512541

Cotinine (COT) Rapid Test Dipstick Box of 50

Hangzhou AllTest Biotech Co., Ltd.

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

• Primary Device ID: 06970277512541
• NIH Device Record Key: 7477e7c4-42b0-47d2-bca0-bc2dd8fe3518
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cotinine (COT) Rapid Test Dipstick
• Version Model Number: DCT-101
• Catalog Number: DCT-101
• Company DUNS: 543254717
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Device Count: 50
• 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	06970277512534 [Unit of Use]
GS1	06970277512541 [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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