EGENS

GUDID 06937579911281

NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

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

• Primary Device ID: 06937579911281
• NIH Device Record Key: 44c56c11-9100-4680-a4d7-c633aae5a7d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EGENS
• Version Model Number: HCG-U35H
• 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	06937579911281 [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 [EGENS]

• 06937579911373: THC-U23
• 06937579911311: LH-U24H
• 06937579911281: HCG-U35H
• 06937579911274: HCG-U35H
• 06937579911267: HCG-U24H
• 06937579911243: HCG-U11H
• 06937579911236: HCG-U11H
• 06937579914619: LH-M
• 06937579914602: LH-C
• 06937579914596: LH-S