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

• 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