| Test Name |
| Document |
Test Type |
Effective Date |
|
Wondfo USA Co., Ltd., Wondfo Early Result Pregnancy Test
|
| K150022 |
hCG, Urine |
07/08/2022 |
|
Wondfo USA Co., Ltd., WellLife COVID-19 Antigen Test (Anterior Nasal Swabs)
|
| K241317 |
SARS-CoV-2 |
03/13/2025 |
|
Wondfo USA Co., Ltd., WellLife COVID-19 Antigen Home Test (Anterior Nasal Swabs)
|
| K241317 |
SARS-CoV-2 |
11/07/2024 |
|
Wondfo USA Co., Ltd., WELLlife COVID-19 / Influenza A&B Home Test (Anterior Nasal Swab)
|
| K243256 |
SARS-CoV-2 and other Respiratory viruses |
01/17/2025 |
|
Wondfo USA Co., Ltd., WELLlife COVID-19 / Influenza A&B Antigen Test (Anterior Nasal Swab)
|
| K243256 |
SARS-CoV-2 and other Respiratory viruses |
01/17/2025 |
|
Wondfo USA Co., Ltd., WELLlife COVID-19 / Flu A&B Home Test (Anterior Nasal Swab)
|
| K243256 |
SARS-CoV-2 and other Respiratory viruses |
02/12/2025 |
|
Wondfo USA Co., Ltd., SAFElife™ T-Dip Methamphetamine (MET/mAMP) Urine Test Panel
|
| K202567 |
Methamphetamines |
11/16/2023 |
|
Wondfo USA Co., Ltd., SAFElife™ T-Dip Amphetamine (AMP) Urine Test Panel
|
| K202567 |
Amphetamines |
10/23/2023 |
|
Wondfo USA Co., Ltd., SAFElife T-Dip Secobarbital (BAR) Urine Test Panel
|
| K202567 |
Secobarbital |
10/30/2023 |
|
Wondfo USA Co., Ltd., SAFElife T-Dip Oxazepam (BZO) Urine Test Panel
|
| K202567 |
Oxazepam |
10/30/2023 |