Multi-Drug Screen Test

GUDID B115VABCUP08660

ADVIN BIOTECH, INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: B115VABCUP08660
• NIH Device Record Key: deb1769b-9b5c-40a3-a505-f118fbfb72b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Drug Screen Test
• Version Model Number: VABCup-08-66
• Company DUNS: 006463333
• Company Name: ADVIN BIOTECH, INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B115VABCUP08660 [Unit of Use]
HIBCC	B115VABCUP08661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252867

FDA Product Code

• NFT: Test, Amphetamine, Over The Counter

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: 2025-12-18
• Device Publish Date: 2025-12-10

On-Brand Devices [Multi-Drug Screen Test]

• B115VABCUP08650: VABCup-08-65
• B115VABCUP15141: VABCup-15-14
• B115VABCUP13721: VABCup-13-72
• B115VABCUP08660: VABCup-08-66