AssureTech Quick Cup Tests

GUDID 06952804830229

ASSURE TECH. (HANGZHOU) CO., LTD.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 06952804830229
• NIH Device Record Key: 143641b3-a77b-423e-bc09-b8dbc8d3d0fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AssureTech Quick Cup Tests
• Version Model Number: 1.0
• 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	06952804830229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181768

FDA Product Code

• QBF: Test, Propoxyphene, 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: 2018-10-08
• Device Publish Date: 2018-09-05

On-Brand Devices [AssureTech Quick Cup Tests]

• 06952804830229: 1.0
• 06952804802639: 15 strips, including MOR2000
• 06952804802615: 15 strips, including MOR300