CIBIO Test

GUDID 06970429841222

12P Rapid Multi-Drug Test Cup

Co-Innovation Biotech Co., Ltd

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

• Primary Device ID: 06970429841222
• NIH Device Record Key: e32a467b-9ced-4b2c-a7a8-375b1214cee9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CIBIO Test
• Version Model Number: DOA12PC
• 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	06970429841222 [Primary]
GS1	06970429841239 [Package]; Package: [25 Units]; In Commercial Distribution
GS1	16970429841236 [Package]; Contains: 06970429841239; Package: [4 Units]; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-10-27

On-Brand Devices [CIBIO Test]

• 06970429841321: 13P Rapid Multi-Drug Test Cup
• 06970429841222: 12P Rapid Multi-Drug Test Cup