Identify®Diagnostics Drug Test Cups ID-CP12-BUP-ADULT

GUDID 20850721007819

Identify®Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 20850721007819
• NIH Device Record Key: 9ad8d656-2583-47df-b1a4-010c115b0dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identify®Diagnostics Drug Test Cups
• Version Model Number: ID-CP12-BUP-ADULT
• Catalog Number: ID-CP12-BUP-ADULT
• 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	00850721007815 [Unit of Use]
GS1	10850721007812 [Primary]
GS1	20850721007819 [Package]; Contains: 10850721007812; Package: case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131811

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

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: 2019-01-04

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

• 20850721007864: Identify®Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/MD
• 20850721007987: "Identify® Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/
• 20850721007963: "Identify® Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/
• 20850721007802: Identify®Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
• 20850721007796: Identify®Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MO
• 20850721007789: Identify®Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MD
• 20850013035070: Identify® Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/M
• 20850013035063: Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
• 20850013035056: Identify® Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/M
• 00850013035113: Identify® Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/M
• 00850013035106: Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
• 00850013035090: Identify® Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/M
• 00850013035083: Identify® Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/M
• 20850721007819: Identify®Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/M
• 20850721007758: Identify®Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MO
• 20850721007741: Identify®Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
• 20850721007734: Identify®Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/MD
• 20850721007727: Identify®Diagnostics Drug Test Cups 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MD
• 20850721007512: Identify®Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC