UCP U-MCUP-794

GUDID 20817038022201

UCP Drug Test Mini Cups 9-Panel Drug Test Mini Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX

UCP BIOSCIENCES, INC.

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

• Primary Device ID: 20817038022201
• NIH Device Record Key: 1072f534-0931-4407-80cb-28dcebe46ff3
• Commercial Distribution Discontinuation: 2033-12-08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP
• Version Model Number: U-MCUP-794
• Catalog Number: U-MCUP-794
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817038022207 [Unit of Use]
GS1	10817038022204 [Primary]
GS1	20817038022201 [Package]; Contains: 10817038022204; Package: case [4 Units]; Discontinued: 2033-12-07; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-12-08

Devices Manufactured by UCP BIOSCIENCES, INC.

• 20817038022270 - 9 Panel Drug Test Cup: 2025-06-16 9 Panel Drug Test Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX
• 20817038022287 - 5 Panel Drug Test Cup: 2025-06-16 5 Panel Drug Test Cup AMP/COC/OPI/THC/PCP
• 20817038022263 - u-CupTM Drug Test Screen: 2025-04-17 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)
• 00817038022252 - 10 Panel Drug Test Cup: 2025-04-01 10 Panel Drug Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
• 20817038022249 - inSight 12 Panel Drug Test Cup: 2024-05-24 inSight 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
• 20817038022225 - OEM 81-13 Drug Test 5 Panel Test Cup: 2024-04-17 OEM 81-13 Drug Test 5 Panel Test Cup AMP/COC/THC/MET/BZO
• 20817038022232 - OEM 81-13 Drug Test 6 Panel Test Cup: 2024-04-17 OEM 81-13 Drug Test 6 Panel Test Cup AMP/COC/THC/MET/BZO/OPI
• 20817038022218 - u-CardTM Drug Test Screen 12 Panel Test Card: 2024-01-12 u-CardTM Drug Test Screen 12 Panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC