DOA Urine Cup 004 MD-U65

GUDID 06952804801885

COC300/AMP1000/MET1000/THC50/MOR 2000

ASSURE TECH. (HANGZHOU) CO., LTD.

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

• Primary Device ID: 06952804801885
• NIH Device Record Key: 592ef14e-2f1a-4ea3-92a7-63c22c1fb72f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOA Urine Cup 004
• Version Model Number: 1.0
• Catalog Number: MD-U65
• Company DUNS: 530757741
• Company Name: ASSURE TECH. (HANGZHOU) 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: false
• 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	06952804801885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170049

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-11

On-Brand Devices [DOA Urine Cup 004]

• 06952804801892: AMP1000/BAR300/BZO300/COC300/MET1000/MOR2000/MTD300/OXY100/PCP25/THC50
• 06952804801885: COC300/AMP1000/MET1000/THC50/MOR 2000