NOBLE

GUDID 30850065976007

NOBLE Multi-Drug Urine Test Cup, 12-Panel, 25T/Box

Guangzhou Decheng Biotechnology Co., LTD

Methamphetamine-specific IVD, kit, rapid ICT, clinical

• Primary Device ID: 30850065976007
• NIH Device Record Key: f3d82ca0-8cda-418e-9df5-c4a662a35ed1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOBLE
• Version Model Number: NMCup-12-01-DK
• 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	00850065976006 [Primary]
GS1	30850065976007 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232659

FDA Product Code

• NGM: Test, Phencyclidine (Pcp), 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 [NOBLE]

• 30850065976564: NOBLE Multi-Drug Urine Test Cup, 7-Panel, 25T/Box
• 30850065976557: NOBLE Multi-Drug Urine Test Dipcard, 7-Panel, 25T/Box
• 00850065976099: NOBLE Multi-Drug Urine Test Dipcard, 10-Panel
• 30850065976083: NOBLE Multi-Drug Urine Test Dipcard, 9-Panel, 25T/Box
• 00850065976075: NOBLE Multi-Drug Urine Test Dipcard, 5-Panel
• 30850065976069: NOBLE Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
• 30850065976007: NOBLE Multi-Drug Urine Test Cup, 12-Panel, 25T/Box
• 30850054867675: NOBLE Multi-Drug Urine Test Cup, 13-Panel, 25T/Box
• 30850054867668: NOBLE Multi-Drug Urine Test Cup, 9-Panel, 25T/Box
• 30850054867651: NOBLE Multi-Drug Urine Test Cup, 8-Panel, 25T/Box
• 30850054867644: NOBLE Multi-Drug Urine Test Cup, 11-Panel, 25T/Box
• 30850054867576: NOBLE Multi-Drug Urine Test Cup, 12-Panel, 25T/Box