UCP Home Drug Screening Test Cups U-CUP-6104-RCN

GUDID 20850721007055

10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 20850721007055
• NIH Device Record Key: 9d6e43e2-215f-4251-a798-10f818a7f20f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP Home Drug Screening Test Cups
• Version Model Number: U-CUP-6104-RCN
• Catalog Number: U-CUP-6104-RCN
• Company DUNS: 064177324
• Company Name: MEDICAL DISTRIBUTION GROUP 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	00850721007051 [Unit of Use]
GS1	10850721007058 [Primary]
GS1	20850721007055 [Package]; Contains: 10850721007058; Package: case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122419

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 Home Drug Screening Test Cups]

• 20850721007253: 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/PCP/AMP/BUP
• 20850721007215: 12 Panel Drug Screening Test Cup THC/COC/OPI300/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
• 20850721007123: 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/PCP/AMP
• 20850721007116: 6 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY/AMP
• 20850721007109: 5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
• 20850721007055: 10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP
• 20850721007048: 6 Panel Drug Screening Test Cup BZO/COC/OPI300/MTD/OXY/BUP
• 10850721007034: 8 Panel Drug Screening Test Cup BZO/BAR/COC/MET/OPI300/MTD/OXY/AMP