QTEST

GUDID 26970429840564

5P DRUG TEST DIPCARD

Co-Innovation Biotech Co., Ltd

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 26970429840564
• NIH Device Record Key: f9e370d9-03e6-4993-a204-dd982500b0a5
• Commercial Distribution Discontinuation: 2018-06-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: QTEST
• Version Model Number: 1
• Company DUNS: 421302978
• Company Name: Co-Innovation Biotech 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970429840560 [Primary]
GS1	16970429840567 [Package]; Contains: 06970429840560; Package: [100 Units]; Discontinued: 2018-06-11; Not in Commercial Distribution
GS1	26970429840564 [Package]; Contains: 16970429840567; Package: [12 Units]; Discontinued: 2018-06-11; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

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: 2018-07-12
• Device Publish Date: 2018-06-11

Devices Manufactured by Co-Innovation Biotech Co., Ltd

• 16970429843315 - co-innovation: 2024-08-28
• 16970429841342 - DTPM: 2023-12-18
• 16970429841632 - DTPM: 2023-12-18
• 16970429840154 - HCG TEST STRIP: 2023-07-06
• 16970429840178 - co-innovation: 2023-05-08
• 16970429841816 - co-innovation: 2022-11-21 Rapid Multi-drug Test Cup
• 16970429841441 - co-innovation: 2022-01-24 14P Drug Test
• 16970429841533 - co-innovation: 2022-01-24 15P Drug Test