mCup®

GUDID 10867802000259

ESCREEN, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10867802000259
• NIH Device Record Key: 60702923-f8c1-42dc-a34b-33c6cfe161fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mCup®
• Version Model Number: MCP11A-001
• Company DUNS: 014079359
• Company Name: ESCREEN, 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
GS1	00867802000252 [Unit of Use]
GS1	10867802000259 [Primary]

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-24

On-Brand Devices [mCup®]

• 10867802000211: MCP5-001
• 10867802000266: MCP5A-001
• 10867802000259: MCP11A-001
• 10867802000242: MCP10A-001
• 10867802000235: MCP9A-001
• 10867802000228: MCP7A-001