AllSource

GUDID 00850065976044

AllSource DRUG DETECTOR, 14-Panel

Guangzhou Decheng Biotechnology Co., LTD

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

• Primary Device ID: 00850065976044
• NIH Device Record Key: d08eeea5-ac79-4f3f-af42-efaf1260e239
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AllSource
• Version Model Number: ALL8145R
• 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: 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	00850065976044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232659

FDA Product Code

• NFY: Test, Cocaine And Cocaine Metabolites, 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 [AllSource]

• 30850065976052: AllSource DRUG DETECTOR, 14-Panel, 25T/Box
• 00850065976044: AllSource DRUG DETECTOR, 14-Panel
• 30850065976021: AllSource DRUG DETECTOR, 7-Panel, 25T/Box
• 30850054867637: AllSource DRUG DETECTOR, 14-Panel, 25T/Box
• 30850054867620: AllSource DRUG DETECTOR, Single-Panel (THC 50), 25T/Box