| Test Name |
| Document |
Test Type |
Effective Date |
|
Wondfo USA Co. Ltd., WELLlife Flu A&B Home Test (Anterior Nasal Swab)
|
| K251563 |
Influenza A/B |
08/21/2025 |
|
Wondfo USA Co, Ltd., Wondfo® PdG Urine Test
|
| CR240206 |
Pregnanediol Glucuronide |
05/14/2024 |
|
Wondfo USA Co, Ltd., Wondfo HCG Early Result Pregnancy Test (Midstream)
|
| K150022 |
Urine hCG by visual color comparison tests |
05/01/2025 |
|
Wondfo USA Co, Ltd., WELLlife iFOB Immunochemical Fecal Occult Blood Test
|
| K162333 |
Fecal occult blood |
08/01/2024 |
|
Wondfo USA Co, Ltd., SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel
|
| K202567 |
Nortriptyline |
12/15/2023 |
|
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup
|
| K182701 |
Oxycodone |
01/03/2025 |
|
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup
|
| K182701 |
Amphetamines |
01/03/2025 |
|
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup
|
| K182701 |
Barbiturates |
01/03/2025 |
|
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup
|
| K182701 |
Benzodiazepines |
01/03/2025 |
|
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup
|
| K182701 |
Phencyclidine (PCP) |
01/03/2025 |
|