Morphine300 Panel Dip

GUDID 06952804801809

ASSURE TECH. (HANGZHOU) CO., LTD.

Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT) Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

• Primary Device ID: 06952804801809
• NIH Device Record Key: 3bdd0d5f-aadc-453c-bc47-f5bd2255e41c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Morphine300 Panel Dip
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06952804801809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170049

FDA Product Code

• NGL: Test, Opiates, 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: 2017-07-24

Devices Manufactured by ASSURE TECH. (HANGZHOU) CO., LTD.

• 06952804805029 - Fastep COVID-19 IgG/IgM Rapid Test Device: 2021-01-27
• 06952804830212 - AssureTech Panel Dip Tests: 2018-10-08 AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300
• 06952804830229 - AssureTech Quick Cup Tests: 2018-10-08
• 06952804802608 - AssureTech Panel Dip Tests: 2018-10-05 15 Strips, including MOR300
• 06952804802615 - AssureTech Quick Cup Tests: 2018-10-05 15 strips, including MOR300
• 06952804802622 - AssureTech Panel Dip Tests: 2018-10-05 15 strips, including MOR2000
• 06952804802639 - AssureTech Quick Cup Tests: 2018-10-05 15 strips, including MOR2000
• 06952804801083 - Panel Dip: 2018-07-06