SIGNAL

GUDID 06937579912127

NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 06937579912127
• NIH Device Record Key: 8b595b86-65cd-4189-b3c2-c6e4120788d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNAL
• Version Model Number: THC-U24
• Company DUNS: 654510689
• Company Name: NANTONG EGENS BIOLOGY TECHNIC 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06937579912127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152643

FDA Product Code

• LAF: Gas Chromatography, Methamphetamine

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: 2018-08-17
• Device Publish Date: 2018-07-17

On-Brand Devices [SIGNAL]

• 06937579912127: THC-U24
• 06937579911250: HCG-U24H