QTEST

GUDID 26970429840564

5P DRUG TEST DIPCARD

Co-Innovation Biotech Co., Ltd

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

• 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

• 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
• 16970429841625 - co-innovation: 2022-01-24 16P Drug Test