| Test Name |
| Document |
Test Type |
Effective Date |
|
Wondfo USA Co., Ltd., HORMONElife Fertility 4 IN 1 Home Test {HORMONElife Ovulation Test Strip}
|
| CR260134 |
Luteinizing hormone (LH) |
04/10/2026 |
|
Wondfo USA Co., Ltd., HORMONElife Early Result Pregnancy Test Strip Rx
|
| K150022 |
Urine hCG by visual color comparison tests |
02/11/2026 |
|
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., HORMONElife Early Result Pregnancy Test Midstream
|
| K150022 |
Urine hCG by visual color comparison tests |
02/09/2026 |
|
Wondfo USA Co., Ltd., BABYlife Ultra Accurate Follicle Stimulating Hormone (FSH) Test Strip
|
| CR230719 |
Follicle stimulating hormone (FSH) |
12/19/2023 |
|
Wondfo USA Co., Ltd., BABYlife DIGITAL PREGNANCY TEST
|
| K222305 |
hCG, Urine |
06/26/2024 |
|
Wondfo USA Co., Ltd. Wondfo Early Result Pregnancy Test Strip
|
| K150022 |
Urine hCG by visual color comparison tests |
07/01/2022 |
|
Wondfo USA Co., Ltd. T-Cup Multi-Drug Urine Test Cup
|
| K133968 |
Amphetamines |
07/27/2018 |
|
Wondfo USA Co., Ltd. T-Cup Multi-Drug Urine Test Cup
|
| K133968 |
Barbiturates |
07/27/2018 |
|
Wondfo USA Co., Ltd. T-Cup Multi-Drug Urine Test Cup
|
| K133968 |
Benzodiazepines |
07/27/2018 |