iScreenTM Oral Fluid Drug Test

GUDID 06936983197090

iScreenTM Oral Fluid Drug Test, EN, 1T

Hangzhou AllTest Biotech Co., Ltd.

Cotinine IVD, kit, rapid ICT, clinical

• Primary Device ID: 06936983197090
• NIH Device Record Key: 7ed83121-d6e0-4b79-84df-648e16e38dc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iScreenTM Oral Fluid Drug Test
• Version Model Number: ABTDCTCUBO0102
• Company DUNS: 543254717
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936983197090 [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: 2025-10-06
• Device Publish Date: 2025-09-26

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