AssureTech Panel Dip Tests

GUDID 06952804801656

ASSURE TECH. (HANGZHOU) CO., LTD.

Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)

• Primary Device ID: 06952804801656
• NIH Device Record Key: d6c7b81e-6ff6-4cd3-9b42-3188565d003a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AssureTech Panel Dip 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	06952804801656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170049

FDA Product Code

• PTG: Test, Methadone, Over The Counter

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: 2017-06-05

On-Brand Devices [AssureTech Panel Dip Tests]

• 06952804830212: AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, ED
• 06952804802646: 12 Strips, including MOR2000
• 06952804802622: 15 strips, including MOR2000
• 06952804802608: 15 Strips, including MOR300
• 06952804801656: 1.0