Panel Dip

GUDID 06952804801083

ASSURE TECH. (HANGZHOU) CO., LTD.

Barbiturate IVD, kit, immunochromatographic test (ICT), rapid Barbiturate IVD, kit, rapid ICT, clinical Barbiturate IVD, kit, rapid ICT, clinical Barbiturate IVD, kit, rapid ICT, clinical Barbiturate IVD, kit, rapid ICT, clinical Barbiturate IVD, kit, rapid ICT, clinical Barbiturate IVD, kit, rapid ICT, clinical

• Primary Device ID: 06952804801083
• NIH Device Record Key: b7ec247f-9069-4fa3-b794-4e93b3d4db5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 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	06952804801083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151211

FDA Product Code

• DIS: Enzyme Immunoassay, Barbiturate

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: 2016-09-19

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
• 06952804801083 - Panel Dip: 2018-07-06