u-Cup TM Drug Test Screen 8 Panel Drug Test Cup U-CUP-384

GUDID 20817038021969

u-Cup TM Drug Test Screen 8 Panel Drug Test Cup BUP/BZO/COC/MET/MTD/MOP/OXY/THC

UCP BIOSCIENCES, INC.

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

• Primary Device ID: 20817038021969
• NIH Device Record Key: 62226eaa-987c-443f-bb6e-f5c35dbdff00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: u-Cup TM Drug Test Screen 8 Panel Drug Test Cup
• Version Model Number: U-CUP-384
• Catalog Number: U-CUP-384
• 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	00817038021965 [Unit of Use]
GS1	10817038021962 [Primary]
GS1	20817038021969 [Package]; Contains: 10817038021962; Package: case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131811

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: 2
• Public Version Date: 2021-05-24
• Device Publish Date: 2018-11-01

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