National Test Systems UCC-10-1

GUDID 20817038021082

10-Panel Drug Test Cup COC/THC/OPI/AMP/MET/BZO/MTD/OXY/MDMA/BUP

UCP BIOSCIENCES, INC.

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

• Primary Device ID: 20817038021082
• NIH Device Record Key: 62cdb0fa-56a5-4b01-9750-40a3106bba3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: National Test Systems
• Version Model Number: UCC-10-1
• Catalog Number: UCC-10-1
• 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	00817038021088 [Unit of Use]
GS1	10817038021085 [Primary]
GS1	20817038021082 [Package]; Contains: 10817038021085; Package: case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151213

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2016-09-30

On-Brand Devices [National Test Systems]

• 20817038021754: National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
• 20817038021747: National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
• 20817038021082: 10-Panel Drug Test Cup COC/THC/OPI/AMP/MET/BZO/MTD/OXY/MDMA/BUP
• 20817038021075: 10-Panel Drug Test Cup COC/THC/OPI/AMP/MET/BZO/MTD/OXY/MDMA/BUP