Identify® Diagnostics Drug Test Cups ID-CP6-BUP

GUDID 20850721007574

Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup BUP/BZO/COC/MOP/OXY/MTD

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 20850721007574
• NIH Device Record Key: 90e3879c-c173-4409-aabf-1e4e0aad379c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identify® Diagnostics Drug Test Cups
• Version Model Number: ID-CP6-BUP
• Catalog Number: ID-CP6-BUP
• 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	00850721007570 [Unit of Use]
GS1	10850721007577 [Primary]
GS1	20850721007574 [Package]; Contains: 10850721007577; 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: 4
• Public Version Date: 2021-05-24
• Device Publish Date: 2017-08-11

On-Brand Devices [Identify® Diagnostics Drug Test Cups]

• 10850721007959: Identify®Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/MD
• 20850721007970: "Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC"
• 00850013035045: Identify® Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/M
• 20850721007666: Identify® Diagnostics Drug Test Cups 5-Panel Drug Screening Test Cup BUP/BZO/MOP/OXY/THC
• 20850721007635: Identify® Diagnostics Drug Test Cups 8-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MTD/MET/MO
• 20850721007574: Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup BUP/BZO/COC/MOP/OXY/MTD
• 20850721007550: Identify® Diagnostics Drug Test Cups 11-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/MDMA/
• 00850013035212: 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY