u-Card U-MDMA-114L

GUDID 20817038021389

u-Card MDMA Single Panel Dip Test Card

UCP BIOSCIENCES, INC.

Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

• Primary Device ID: 20817038021389
• NIH Device Record Key: 7a47989e-0d85-4f4f-a6e2-e0a03bc848ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: u-Card
• Version Model Number: U-MDMA-114L
• Catalog Number: U-MDMA-114L
• Company DUNS: 163610020
• Company Name: UCP BIOSCIENCES, 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: true
• RX Perscription: true
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817038021385 [Unit of Use]
GS1	10817038021382 [Primary]
GS1	20817038021389 [Package]; Contains: 10817038021382; Package: case [40 Units]; In Commercial Distribution

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2017-01-20

On-Brand Devices [u-Card]

• 20817038021402: u-Card BZO Single Panel Dip Test Card
• 20817038021396: u-Card BAR Single Panel Dip Test Card
• 20817038021389: u-Card MDMA Single Panel Dip Test Card
• 10817038021375: u-Card COC Single Panel Dip Test Card