THE SOLUTION

GUDID 30021331054501

Sakar International, Inc.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 30021331054501
• NIH Device Record Key: f4c071f0-fa12-4a21-afd4-a0262a1dd25b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THE SOLUTION
• Version Model Number: 150AUCMUC14
• Company DUNS: 086413028
• Company Name: Sakar International, Inc.
• Device Count: 2
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021331054500 [Primary]
GS1	30021331054501 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180349

FDA Product Code

• NFT: Test, Amphetamine, Over The Counter

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: 2022-07-20
• Device Publish Date: 2022-07-12

On-Brand Devices [THE SOLUTION]

• 30681066053998: 139AUCMUC03
• 30681066053707: 160THCDCA06
• 30681066049601: 105THCSTR03
• 30021331054501: 150AUCMUC14