Amazewell

GUDID 30850054867606

Amazewell™ Multi-Drug Urine Test Clicker Cup, 6-Panel, 25T/Box

Guangzhou Decheng Biotechnology Co., LTD

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

• Primary Device ID: 30850054867606
• NIH Device Record Key: 6a597d31-85a9-46a7-9fcf-89aab14540c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amazewell
• Version Model Number: ASUD-264
• 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	00850054867605 [Primary]
GS1	30850054867606 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232659

FDA Product Code

• NFW: Test, Cannabinoid, 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: 2024-10-08
• Device Publish Date: 2024-09-30

On-Brand Devices [Amazewell]

• 30850054867194: Amazewell™ Lollipop Oral Fluid Drug Test, 5-Panel, 25T/Box
• 30850054867187: Amazewell™ Lollipop Oral Fluid Drug Test, 6-Panel, 25T/Box
• 30850054867170: Amazewell™ Lollipop Oral Fluid Drug Test, 4-Panel, 25T/Box
• 30850054867163: Amazewell™ Lollipop Oral Fluid Drug Test, 5-Panel, 25T/Box
• 30850054867149: Amazewell™ Lollipop Oral Fluid Drug Test, 10-Panel, 25T/Box
• 30850054867095: Amazewell™ D-Pen™ Oral Fluid Drug Test, 6-Panel , 25T/Box
• 30850054867088: Amazewell™ D-Pen™ Oral Fluid Drug Test, 5-Panel, 25T/Box
• 30850054867071: Amazewell™ D-Pen™ Oral Fluid Drug Test, 9-Panel, 25T/Box
• 30850054867064: Amazewell™ Multi-Drug Urine Test Clicker Cup, 12-Panel, 25T/Box
• 30850054867057: Amazewell™ D-Pen™ Oral Fluid Drug Test, 11-Panel, 25T/Box
• 30850054867040: Amazewell™ D-Pen™ Oral Fluid Drug Test, 10-Panel, 25T/Box
• 30850054867033: Amazewell™ D-Pen™ Mini THC Oral Fluid Test, 10T/Box
• 30850054867026: Amazewell™ D-Pen™ Mini COT Oral Fluid Test, 10T/Box
• 30850054867019: Amazewell Ovulation and Pregnancy Combo Test Kit, Strip, 50 LH + 20 HCG, 70T/Box
• 30850054867002: Amazewell Ovulation and Pregnancy Combo Test Kit, Strip, 10 LH + 2 HCG, 12T/Bag
• 30850065976519: Amazewell™ Multi-Drug Urine Test Dipcard, 10-Panel, 25T/Box
• 30850065976502: Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
• 30850065976496: Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
• 30850065976489: Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
• 30850065976472: Amazewell™ Multi-Drug Urine Test Dipcard, 6-Panel, 25T/Box
• 30850065976465: Amazewell™ Multi-Drug Urine Test Dipcard, 5-Panel, 25T/Box
• 30850065976458: Amazewell™ Multi-Drug Urine Test Dipcard, 5-Panel, 25T/Box
• 30850054867989: Amazewell™ Multi-Drug Urine Test Clicker Cup, 5-Panel, 25T/Box
• 30850054867965: Amazewell™ D-Pen™ Oral Fluid Drug Test, 10-Panel, 25T/Box
• 30850054867897: Amazewell™ D-Pen™ Oral Fluid Drug Test, 9-Panel, 25T/Box
• 00850054867841: Amazewell™ Multi-Drug Urine Test Clicker Cup, 13-Panel
• 00850054867803: Amazewell™ D-Pen™ Oral Fluid Drug Test, 7-Panel
• 00850054867797: Amazewell™ D-Pen™ Oral Fluid Drug Test, 6-Panel
• 00850054867773: Amazewell™ D-Pen™ Oral Fluid Drug Test, 9-Panel
• 30850054867453: Amazewell™ Ovulation Rapid Test Midstream, 20T/Box
• 30850054867446: Amazewell™ Digital Ovulation Test Kit, 10T/Box
• 30850054867439: Amazewell™ Pregnancy Rapid Test Strip, 5T/Bag
• 30850054867422: Amazewell™ Pregnancy Rapid Test Strip, 25T/Box
• 30850054867415: Amazewell™ Pregnancy Rapid Test Midstream, 2T/Box
• 00850054867407: Amazewell™ Pregnancy Rapid Test Midstream, 1T/Box
• 30850054867392: Amazewell™ Digital Pregnancy Rapid Test, 5T/Box
• 00850054867384: Amazewell™ Digital Pregnancy Rapid Test, 1T/Box
• 30850054867316: Amazewell™ Multi-Drug Urine Test Clicker Cup, 10-Panel, 25T/Box
• 30850054867286: Amazewell™ Multi-Drug Urine Test Clicker Cup, 12-Panel, 25T/Box
• 30850054867279: Amazewell™ Multi-Drug Urine Test Clicker Cup, 12-Panel, 25T/Box
• 30850054867262: Amazewell™ Multi-Drug Urine Test Clicker Cup, 6-Panel, 25T/Box
• 30850054867255: Amazewell™ Multi-Drug Urine Test Clicker Cup, 12-Panel, 25T/Box
• 30850054867248: Amazewell™ Multi-Drug Urine Test Clicker Cup, 5-Panel, 25T/Box
• 30850054867231: Amazewell™ Multi-Drug Urine Test Clicker Cup, 13-Panel, 25T/Box
• 30850054867224: Amazewell™ Multi-Drug Urine Test Clicker Cup, 14-Panel, 25T/Box
• 30850054867132: Amazewell™ D-Pen™ Oral Fluid Drug Test, 5-Panel, 25T/Box
• 30850054867118: Amazewell™ D-Pen™ Oral Fluid Drug Test, 4-Panel , 25T/Box
• 30850054867101: Amazewell™ D-Pen™ Oral Fluid Drug Test, 7-Panel , 25T/Box
• 00850054867735: Amazewell™ D-Pen™ Oral Fluid Drug Test, 8-Panel
• 00850054867728: Amazewell™ D-Pen™ Oral Fluid Drug Test, 7-Panel