Dochek

GUDID 06974464590138

Rapid Multi-drug Test CUP-6 panel

Guangzhou Decheng Biotechnology Co., LTD

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

• Primary Device ID: 06974464590138
• NIH Device Record Key: 6979e40a-4a70-488a-b7c2-d6a654b8ac0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dochek
• Version Model Number: 4831U2X001
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974464590138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

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: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [Dochek]

• 06974464590152: Rapid Multi-drug Test Cup, 10 Panel
• 06974464590145: Rapid Multi-drug Test Dipcard, 10-Panel
• 06974464590138: Rapid Multi-drug Test CUP-6 panel
• 06974464590121: Rapid Multi-drug Test Dipcard -6 Panel
• 06974464590091: THC urine test card