HORMONElife™

GUDID 10816862027249

HORMONElife™ Ultra Accurate FSH Test Strip OTC 6PK

WONDFO USA CO., LTD.

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 10816862027249
• NIH Device Record Key: 356154ba-16c6-4790-bdc5-1be0853026d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HORMONElife™
• Version Model Number: W52-S-SQ-6BX
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 6
• 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: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862027235 [Unit of Use]
GS1	00816862027242 [Primary]
GS1	10816862027249 [Package]; Contains: 00816862027242; Package: [160 Units]; In Commercial Distribution

FDA Product Code

• NGA: Test, Follicle Stimulating Hormone (Fsh), 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: 2025-07-11
• Device Publish Date: 2025-07-03

On-Brand Devices [HORMONElife™]

• 10816862027263: HORMONElife™ PdG Urine Test Strip OTC 6PK
• 10816862027249: HORMONElife™ Ultra Accurate FSH Test Strip OTC 6PK