EGENS

GUDID 06937579914619

NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

• Primary Device ID: 06937579914619
• NIH Device Record Key: de25e2c9-5394-4e71-b2fb-4348b506f180
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EGENS
• Version Model Number: LH-M
• Company DUNS: 654510689
• Company Name: NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	06937579914619 [Primary]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), Over The Counter

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: 2023-08-21
• Device Publish Date: 2023-08-11

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