UCP Compact Drug Test Cards UCD-10-1-CLIA

GUDID 20817038020801

10-Panel Drug Test Card COC/THC/OPI/AMP/MET/PCP/BZO/BAR/MTD/OXY

UCP BIOSCIENCES, INC.

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

• Primary Device ID: 20817038020801
• NIH Device Record Key: c9f5c7ef-d323-4ba9-a946-7570bf0c0321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP Compact Drug Test Cards
• Version Model Number: UCD-10-1-CLIA
• Catalog Number: UCD-10-1-CLIA
• 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	00817038020807 [Unit of Use]
GS1	10817038020804 [Primary]
GS1	20817038020801 [Package]; Contains: 10817038020804; 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: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-08-30

On-Brand Devices [UCP Compact Drug Test Cards]

• 20817038021761: UCP Compact Drug Test Cards 6-Panel Drug Test Card COC/OPI/MTD/BZO/OXY/THC
• 20817038020856: 10-Panel Drug Test Card COC/THC/MOP/AMP/MET/BZO/BAR/MTD/OXY/BUP
• 20817038020832: 12-Panel Drug Test Card COC/THC/OPI/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
• 20817038020818: 12-Panel Drug Test Card COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/TCA
• 20817038020801: 10-Panel Drug Test Card COC/THC/OPI/AMP/MET/PCP/BZO/BAR/MTD/OXY
• 20817038020795: 5-Panel Drug Test Card COC/THC/OPI/AMP/BZO
• 20817038020849: BUP Single Panel Dip Test Card