| Primary Device ID | 00816862028096 |
| NIH Device Record Key | 8962a66b-0e8f-4c3d-9d35-8baefad6bdc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HORMONElife™ |
| Version Model Number | H2-S-50BG |
| Company DUNS | 849098897 |
| Company Name | WONDFO USA CO., LTD. |
| Device Count | 25 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816862028096 [Unit of Use] |
| GS1 | 00816862028102 [Primary] |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-23 |
| Device Publish Date | 2025-12-15 |
| 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 |