Identify Diagnostics USA ID-US8-1-AZ25

GUDID 00850013035151

dentify Diagnostics USA 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO300, COC150, EDDP300, MET500, MOP300, OXY100 25 Test/Box

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 00850013035151
• NIH Device Record Key: f1b4b7d1-ed2a-4ac4-a00f-42ce50bf2b97
• Commercial Distribution Discontinuation: 2099-03-02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identify Diagnostics USA
• Version Model Number: ID-US8-1
• Catalog Number: ID-US8-1-AZ25
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013035151 [Unit of Use]
GS1	10850013035158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazepine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-03
• Device Publish Date: 2022-01-26

On-Brand Devices [Identify Diagnostics USA]

• 20850721007895: Identify Diagnostics USA Drug Test Dip Card - AMP500/BAR300/BUP10/BZO300/COC150/MET500/MTD300/OP
• 20850721007888: IDENTIFY DIAGNOSTICS USA DRUG SCREEN CUP AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET50
• 20850721007949: (Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - AMP500, BZO300, COC150, MOR/OPI300,
• 20850721007932: (Identify USA - Drug Test Cups) / 12 Panel CLIA Waived Cup - AMP500, BAR300, BUP10, BZO300, COC
• 00850013035137: Identify Diagnostics USA Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
• 00850013035144: (Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - BUP10, BZO300, COC150, MTD300, MOR30
• 00850013035151: dentify Diagnostics USA 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO
• 00850013035168: Identify Diagnostics USA 9 Panel Drug Test Cup w/ Adulterations CLIA Waived MADE IN USA AMP500,
• 00850013035175: IDENTIFY DIAGNOSTICS USA DRUG SCREEN TEST CUP AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/