UScreen

GUDID 30850065976168

UScreen™ RAPID DRUG TEST CUP, 13-Panel, 25T/Box

Guangzhou Decheng Biotechnology Co., LTD

Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

• Primary Device ID: 30850065976168
• NIH Device Record Key: 8e8337f4-4610-4d3b-9f7a-2fa68c214048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UScreen
• Version Model Number: USSCUP-13CLIA
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850065976167 [Primary]
GS1	30850065976168 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232659

FDA Product Code

• NGL: Test, Opiates, 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: 2024-10-07
• Device Publish Date: 2024-09-29

On-Brand Devices [UScreen]

• 30850065976274: UScreen™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
• 30850065976250: UScreen™ Multi-Drug Urine Test Dipcard, 10-Panel, 25T/Box
• 30850065976243: UScreen™ Multi-Drug Urine Test Dipcard, 10-Panel, 25T/Box
• 00850065976235: UScreen™ Multi-Drug Urine Test Dipcard, 10-Panel
• 30850065976168: UScreen™ RAPID DRUG TEST CUP, 13-Panel, 25T/Box
• 30850065976151: UScreen™ RAPID DRUG TEST CUP, 13-Panel, 25T/Box
• 30850065976137: UScreen™ RAPID DRUG TEST CUP, 10-Panel, 25T/Box
• 30850065976120: UScreen™ RAPID DRUG TEST CUP, 10-Panel, 25T/Box
• 30850065976113: UScreen™ RAPID DRUG TEST CUP, 10-Panel, 25T/Box
• 30850065976106: UScreen™ RAPID DRUG TEST CUP, 5-Panel, 25T/Box
• 30850054867941: UScreen™ RAPID DRUG TEST CUP, 14 Panel, 25T/Box
• 30850054867934: UScreen™ RAPID DRUG TEST CUP, 10-Panel, 25T/Box
• 30850054867927: UScreen™ RAPID DRUG TEST CUP, 12-Panel, 25T/Box
• 30850054867910: UScreen™ RAPID DRUG TEST CUP, 12-Panel, 25T/Box
• 30850054867903: UScreen™ RAPID DRUG TEST CUP, 12-Panel, 25T/Box