DTPM

GUDID 16970429841342

Co-Innovation Biotech Co., Ltd

Amphetamine-specific IVD, kit, rapid ICT, clinical

• Primary Device ID: 16970429841342
• NIH Device Record Key: ae45a749-a205-45a3-b313-a006af2d1b0e
• Commercial Distribution Discontinuation: 2023-12-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DTPM
• Version Model Number: 13P
• 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	06970429841345 [Primary]
GS1	16970429841342 [Package]; Contains: 06970429841345; Package: [25 Units]; Discontinued: 2023-11-10; Not in Commercial Distribution
GS1	26970429841349 [Package]; Contains: 06970429841345; Package: [100 Units]; Discontinued: 2023-11-10; Not in Commercial Distribution
GS1	36970429841346 [Package]; Contains: 06970429841345; Package: [210 Units]; Discontinued: 2023-11-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

FDA Product Code

• DIS: Enzyme Immunoassay, Barbiturate

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: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [DTPM]

• 16970429841632: 16P
• 16970429841342: 13P