UScreen Oral

GUDID 30850065976298

UScreen Oral® Saliva Drug Test Pen, 10-Panel, 25T/Box

Guangzhou Decheng Biotechnology Co., LTD

Amphetamine-specific IVD, kit, rapid ICT, clinical

• Primary Device ID: 30850065976298
• NIH Device Record Key: 5a25e200-15be-4824-9260-f2cfe3cdb707
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UScreen Oral
• Version Model Number: USSORAL-10BUP-EUO
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850065976297 [Primary]
GS1	30850065976298 [Unit of Use]

FDA Product Code

• PUX: Test, Amphetamine, Employment And Insurance Testing, Exempt

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: 2024-09-27

On-Brand Devices [UScreen Oral]

• 00850065976303: UScreen Oral® Saliva Drug Test Pen, 10-Panel
• 30850065976298: UScreen Oral® Saliva Drug Test Pen, 10-Panel, 25T/Box
• 30850065976281: UScreen Oral® Saliva Drug Test Pen, 5 Panel, 25T/Box