AICARE

GUDID 26970429843114

THC Screen Test Dipcard

Co-Innovation Biotech Co., Ltd

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

• Primary Device ID: 26970429843114
• NIH Device Record Key: 9ac2c132-c11f-45e3-b3b2-44b40891c8b7
• Commercial Distribution Discontinuation: 2019-03-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AICARE
• Version Model Number: THC Screen Test
• 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: false
• 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	06970429843110 [Primary]
GS1	16970429843117 [Package]; Contains: 06970429843110; Package: [15 Units]; Discontinued: 2019-03-18; Not in Commercial Distribution
GS1	26970429843114 [Package]; Contains: 06970429843110; Package: [25 Units]; Discontinued: 2019-03-18; 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: 2019-03-26
• Device Publish Date: 2019-03-18

On-Brand Devices [AICARE]

• 26970429843114: THC Screen Test Dipcard
• 06970429840577: Multi Drug Screen Test Dipcard
• 26970429840120: HCG Pregnancy Test Strip