AssureTech Quick Cup Test

GUDID 06952804802653

12 strips, including MOR2000

ASSURE TECH. (HANGZHOU) CO., LTD.

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

• Primary Device ID: 06952804802653
• NIH Device Record Key: 25a64c7f-dabf-4e68-adc0-964c4f6d8c6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AssureTech Quick Cup Test
• 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	06952804802653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170049

FDA Product Code

• PTH: Test, Barbiturate, 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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-17

On-Brand Devices [AssureTech Quick Cup Test]

• 06952804802653: 12 strips, including MOR2000
• 06952804801649: 1.0