Identify Diagnostics USA ID-US1-DIP-THC

GUDID 00850013035137

Identify Diagnostics USA Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 00850013035137
• NIH Device Record Key: fabfc0ec-e325-4be7-b38b-d59f06e6b246
• Commercial Distribution Discontinuation: 2040-05-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identify Diagnostics USA
• Version Model Number: ID-US1-DIP-THC
• Catalog Number: ID-US1-DIP-THC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013035137 [Unit of Use]
GS1	10850013035134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

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: 2021-08-31
• Device Publish Date: 2021-08-23

On-Brand Devices [Identify Diagnostics USA]

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• 00850013035137: Identify Diagnostics USA Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
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• 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,
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