HORMONElife™

GUDID 10816862027263

HORMONElife™ PdG Urine Test Strip OTC 6PK

WONDFO USA CO., LTD.

Multiple female fertility marker IVD, kit, rapid ICT, clinical

• Primary Device ID: 10816862027263
• NIH Device Record Key: d8d4560f-0982-47c7-bf10-35de6ce29c47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HORMONElife™
• Version Model Number: W199-S-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

Customer Support Contacts

• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com

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	00816862027259 [Unit of Use]
GS1	00816862027266 [Primary]
GS1	10816862027263 [Package]; Contains: 00816862027266; Package: [160 Units]; In Commercial Distribution

FDA Product Code

• QKE: Immunoassay, Pregnanediol Glucuronide, 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
• 00816862027754: HORMONElife™ Pregnancy Home Test Midstream
• 00816862027747: HORMONElife™ Early Result Pregnancy Test Midstream
• 00810174471113: HORMONELife 50+100 Strip Combo; 50 hCG Pregnancy Test + 100 LH Ovulation
• 00810174471090: HORMONELife 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation
• 00810174471076: HORMONELife 15+40 Strip Combo; 15 hCG Pregnancy Test + 40 LH Ovulation
• 00810174471052: HORMONELife 10+20 Strip Combo; 10 hCG Pregnancy Test + 20 LH Ovulation
• 00816862028119: HORMONElife™ Pregnancy Test Cassette Rx; 25 mIU/mL CLIA Waived; 25 Tests per Kitbox
• 00816862028096: HORMONElife™ Ovulation Test Strip; 25 mIU/mL OTC; 50 Tests per Bag