FDA Registration
Active
🇺🇸 United States
Wondfo USA Co., Ltd.
Reg #: 3016252795
·
FEI: 3016252795
·
Expires 2026
Products
4
Proprietary Names
18
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Wondfo USA Co., Ltd.
- Registration Number
- 3016252795
- FEI Number
- 3016252795
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6720 Cobra Way
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251563
Owner / Operator
- Firm Name
- Wondfo USA Co., Ltd.
- Operator Number
- 10028951
- Address
- 890 REMINGTON BLVD
- City
- Bolingbrook
- State
- IL
- Postal Code
- 60440
- Country
- US
- Correspondent
- Kunyuan Mao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2024-05-14 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2018-05-05 |
| Kit, Direct Antigen, Positive Control | MJZ | Class 1 | Clinical Chemistry | No | 2025-09-10 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | Class 2 | Microbiology | No | 2025-09-10 |
Proprietary Names
WELLlife COVID-19 / Influenza A&B Test
WELLlife COVID-19 / Influenza A&B Home Test
Toptolife Strep A Test
Preview® Strep A Test Kit
WELLlife COVID-19 Antigen Test Rx Control Kit
WELLlife Influenza A&B Test Control Kit
WELLlife COVID-19 / Influenza A&B Antigen Test Control Kit
QuickVue Influenza+SARS Test Control Kit
INDICAID COVID-19 / INFLUENZA A&B ANTIGEN TEST CONTROL KIT
WELLlife Flu A&B Home Test
WELLlife Influenza A&B Test
MEDLINE Flu A & B Rapid Antigen Cassette Test
INDICAID COVID-19 / INFLUENZA A&B ANTIGEN TEST
QuickVue Influenza+SARS Test
INDICAID COVID-19 / Flu A&B Home Test
WELLlife COVID-19 / Influenza A&B Antigen Test
WELLlife COVID-19 / Flu A&B Home Test
2San 3 in 1 COVID-19 + Flu A&B Rapid Self-Test
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198