UCP Drug Test Mini Cups U-MCUP-1246-POC

GUDID 20817038020733

6-Panel Drug Test Mini Cup OXY/OPI300/COC/BZO/AMP/MET

UCP BIOSCIENCES, INC.

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

• Primary Device ID: 20817038020733
• NIH Device Record Key: 895e2da7-75b3-4254-92aa-6721147ebe13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP Drug Test Mini Cups
• Version Model Number: U-MCUP-1246-POC
• Catalog Number: U-MCUP-1246-POC
• 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
• 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
• 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	00817038020739 [Unit of Use]
GS1	10817038020736 [Primary]
GS1	20817038020733 [Package]; Contains: 10817038020736; Package: case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151213

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2021-05-24
• Device Publish Date: 2016-08-30

On-Brand Devices [UCP Drug Test Mini Cups ]

• 20817038021938: UCP Drug Test Mini Cups 6-Panel Drug Test Mini Cup AMP/BZO/COC/MET/OPI300/OXY
• 20817038021778: UCP Drug Test Mini Cups 12-Panel Drug Test Mini Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/
• 20817038020764: 6-Panel Drug Test Mini Cup BZO/COC/OXY/OPI300/AMP/BUP
• 20817038020757: 12-Panel Drug Test Mini Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/TCA/BUP
• 20817038020740: 6-Panel Drug Test Mini Cup BZO/COC/THC/OXY/OPI300/AMP
• 20817038020733: 6-Panel Drug Test Mini Cup OXY/OPI300/COC/BZO/AMP/MET
• 20817038022089: UCP Drug Test Mini Cups 10-Panel Drug Test Mini Cup AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
• 20817038022102: UCP Drug Test Mini Cups 5-Panel Drug Test Mini Cup AMP/COC/OPI/THC/PCP