co-innovation

GUDID 36970429840622

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: 36970429840622
• NIH Device Record Key: cec2b50c-aaa7-4da6-8eb1-4e2b775f85fb
• Commercial Distribution Discontinuation: 2018-08-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: co-innovation
• Version Model Number: 6P Drug Test Dipcard
• 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	06970429840621 [Primary]
GS1	16970429840628 [Package]; Contains: 06970429840621; Package: [25 Units]; Discontinued: 2018-08-29; Not in Commercial Distribution
GS1	26970429840625 [Package]; Contains: 06970429840621; Package: [100 Units]; Discontinued: 2018-08-29; Not in Commercial Distribution
GS1	36970429840622 [Package]; Contains: 26970429840625; Package: [12 Units]; Discontinued: 2018-08-29; 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: 2018-10-01
• Device Publish Date: 2018-08-29

On-Brand Devices [co-innovation]

• 06970429841420: 14P DRUG TEST CUP
• 16970429841410: 14P Rapid Multi-Drug Test Cup
• 26970429841288: 12P drug test cup
• 36970429841278: 12P Drug Test Dipcard
• 36970429841261: 12P DRUG TEST DIPCARD
• 16970429841250: 12P Rapid Multi-Drug Test Cup
• 26970429841110: Rapid Multi drug Test Cup 11 Pannel
• 16970429840710: 7P Rapid Multi-Drug Test Cup
• 16970429840635: Rapid ETG Test Dipcard
• 36970429840622: 6P Drug Test Dipcard
• 06970429840539: Rapid THC Test Dipcard
• 06970429840614: THC Strip/3.0mm
• 06970429840423: OPI Test Strip
• 06970429840317: 3P Drug Test Dipcard
• 06970429840416: HCG Cassette
• 06970429840218: HCG Strip/4.0mm
• 16970429841618: 16P CUP
• 16970429841908: 12P Drug Test
• 16970429841809: 18P Drug Test
• 16970429841700: 17P Drug Test
• 16970429841625: 16P Drug Test
• 16970429841533: 15P Drug Test
• 16970429841441: 14P Drug Test
• 16970429841816: Rapid Multi-drug Test Cup
• 16970429840178: HCG TEST