SIGNAL

GUDID 06937579911250

NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD, calibrator

• Primary Device ID: 06937579911250
• NIH Device Record Key: f782a6c3-5af4-4ffc-aee0-b4a4bd88129d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNAL
• Version Model Number: HCG-U24H
• 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: true
• 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	06937579911250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123050

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-20

On-Brand Devices [SIGNAL]

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