| Test Name |
| Document |
Test Type |
Effective Date |
|
Wondfo USA Co., Ltd., HORMONElife Ultra Accurate Ovulation Test Strip
|
| CR250101 |
Luteinizing hormone (LH) |
04/08/2025 |
|
Wondfo USA Co., Ltd., HORMONElife Ultra Accurate FSH Test Strip
|
| CR240759 |
Follicle stimulating hormone (FSH) |
01/13/2025 |
|
Wondfo USA Co., Ltd., HORMONElife Pregnancy Test Strip
|
| K043443 |
Urine hCG by visual color comparison tests |
04/07/2025 |
|
Wondfo USA Co., Ltd., HORMONElife Pregnancy Home Test Midstream
|
| K043443 |
Urine hCG by visual color comparison tests |
05/02/2025 |
|
Wondfo USA Co., Ltd., HORMONElife PdG Urine Test Strip
|
| CR250085 |
Pregnanediol Glucuronide |
04/07/2025 |
|
Wondfo USA Co., Ltd., HORMONElife Ovulation Test Strip
|
| CR250084 |
Ovulation test (LH) By visual color comparison |
04/03/2025 |
|
Wondfo USA Co., Ltd., HORMONElife Fertility Combination Tests {HORMONElife Ovulation Test Strip}
|
| CR250599 |
Luteinizing hormone (LH) |
10/28/2025 |
|
Wondfo USA Co., Ltd., HORMONElife Fertility Combination Tests {HORMONElife Pregnancy Test Strip}
|
| K043443 |
Urine hCG by visual color comparison tests |
10/28/2025 |
|
Wondfo USA Co., Ltd., HORMONElife Early Result Pregnancy Test Strip
|
| K150022 |
Urine hCG by visual color comparison tests |
05/28/2025 |
|
Wondfo USA Co., Ltd., BABYlife Ultra Accurate Follicle Stimulating Hormone (FSH) Test Strip
|
| CR230719 |
Follicle stimulating hormone (FSH) |
12/19/2023 |