| Test Name |
| Document |
Test Type |
Effective Date |
|
Wondfo USA Co., Ltd., SAFElife C-Cup Multi-Drug Urine Test Cup
|
| K252550 |
Fentanyl |
01/26/2026 |
|
Wondfo USA Co., Ltd., SAFElife C-Cup Multi-Drug Urine Test Cup
|
| K252550 |
Norfentanyl |
01/26/2026 |
|
Wondfo USA Co., Ltd., SAFElife C-Cup Multi-Drug Urine Test Cup
|
| K252550 |
Tramadol |
01/26/2026 |
|
Wondfo USA Co., Ltd., PRIME SCREEN Single Panel Urine Test Oxazepam (BZO)
|
| K202567 |
Oxazepam |
04/14/2025 |
|
Wondfo USA Co., Ltd., Prime Screen Single Panel Urine Test Cannabinoids (THC)
|
| K202567 |
Cannabinoids (THC) |
07/13/2022 |
|
Wondfo USA Co., Ltd., Prime Screen Saliva Alcohol Test Strip
|
| K111206 |
Ethanol (alcohol) |
02/21/2025 |
|
Wondfo USA Co., Ltd., Preview Fertility Combination Tests {Preview Pregnancy Test Strip}
|
| K043443 |
Urine hCG by visual color comparison tests |
08/19/2020 |
|
Wondfo USA Co., Ltd., Preview Fertility Combination Tests {Preview Ovulation Test Strip}
|
| CR200366 |
Luteinizing hormone (LH) |
08/19/2020 |
|
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 |