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Sign in to claim this brandWONDFO USA CO., LTD.
US
Last updated September 17, 2026
What WONDFO USA CO., LTD. makes
The company manufactures in vitro diagnostic (IVD) devices for detecting drugs of abuse, human chorionic gonadotropin (hCG), fentanyl, SARS-CoV-2 antigen, luteinizing hormone (LH), and multiple-genus respiratory viruses. Products include rapid immunoassay kits, self-testing devices, and clinical test formats, as well as natural conception assistance kits. Examples include dip cards, compact test cups, and rapid screening devices for point-of-care and home use.
These devices are regulated under FDA’s In Vitro Diagnostic Device (IVD) classification system, including Class I and Class II devices, as well as non-classified (N) and unclassified (U) products. They are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Wondfo USA Co., Ltd. manufacture?
Wondfo USA Co., Ltd. specializes in in vitro diagnostic (IVD) devices. Their products primarily focus on detecting substances like drugs of abuse, human chorionic gonadotropin (hCG), fentanyl, SARS-CoV-2 antigen, luteinizing hormone (LH), and multiple-genus respiratory viruses. These devices come in various formats, including rapid immunoassay kits, self-testing devices, and clinical test kits. They also produce natural conception assistance kits, catering to both point-of-care and home testing needs.
Where is Wondfo USA Co., Ltd. based?
Wondfo USA Co., Ltd. is based in the United States. This location allows them to align with U.S. regulatory requirements, including those for in vitro diagnostic devices.
Which regulatory registries list Wondfo USA Co., Ltd.’s devices?
Wondfo USA Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized IVD products, including those classified under the FDA’s system.
How are Wondfo USA Co., Ltd.’s devices classified under FDA regulations?
Wondfo USA Co., Ltd.’s devices fall under the FDA’s In Vitro Diagnostic Device (IVD) classification system. Their products are categorized as Class I, Class II, non-classified (N), or unclassified (U) based on their risk levels and intended use. For example, lower-risk devices like some rapid test kits may be Class I, while higher-risk or more complex diagnostics could be Class II. The classification determines regulatory oversight and submission requirements.
What kinds of testing formats do Wondfo USA Co., Ltd.’s IVD devices include?
Wondfo USA Co., Ltd.’s IVD devices include rapid immunoassay kits designed for point-of-care and home use, such as dip cards (e.g., *Wondfo Drug Test Dip Card*), compact test cups (e.g., *T-Cup Compact*), and self-testing formats for detecting substances like SARS-CoV-2 antigen or respiratory viruses. Clinical versions are also available for laboratory settings, ensuring flexibility across different testing environments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 890 Remington Blvd, Bolingbrook, IL, 60440
- Website
- wondfousa.com
- —
- —
- [email protected]
- Phone
- 630-468-2199
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3007606081
- DUNS Number
- 849098897
Catalogue (417)
Page 9 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Prime Screen | DWDOA-754-5BX-A | FDA UDI | Class II | Active |
| PrimeScreen | DWDTH-114-5BX-A | FDA UDI | Class II | Active |
| SAFElife™ | WFTY-OTC1-25BX | FDA UDI | Class II | Active |
| Preview | PRE-PDOA-4144A3 | FDA UDI | Class II | Active |
| Preview | PRE-PDOA-664 | FDA UDI | Class II | Active |
| Preview | PRE-FIT-OTC | FDA UDI | Class II | Active |
| Preview | PRE-H20L50 | FDA UDI | Class I | Active |
| Wondfo Drug Test Dip Card | WDOA-264 | FDA UDI | Class II | Active |
| SAFElife™ | CDOA-6124A3 | FDA UDI | Class II | Active |
| Prime Screen | DUDOA-1144-5BX-A | FDA UDI | Class II | Active |
| T-Cup Flat | FDOA-6125 | FDA UDI | Class II | Active |
| Preview | PRE-HCG-25S | FDA UDI | Class II | Active |
| Wondfo Drug Test Dip Card | WDOA-7125 | FDA UDI | Class II | Active |
| T-Cup | TDOA-3104A3 | FDA UDI | Class II | Active |
| Wondfo Drug Test Dip Card | WDOA-144 | FDA UDI | Class II | Active |
| WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | K251563 | FDA 510(k) | Class II | Active |
| WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest | K243256 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Wondfo USA Co., Ltd. has five recall records, all initiated on April 22, 2024. The records include both open and classified statuses, with the sole reason cited being the unauthorized distribution of the Preview Strep A Test Kit, including sales and distribution for at-home, non-prescription, over-the-counter, or direct-to-consumer use.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 22, 2024 | Z-2031-2024 | — | open, classified | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers. |
| Apr 22, 2024 | Z-2032-2024 | — | open, classified | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers. |
| Apr 22, 2024 | Z-2034-2024 | — | open, classified | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers. |
| Apr 22, 2024 | Z-2033-2024 | — | open, classified | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers. |
| Apr 22, 2024 | Z-2030-2024 | — | open, classified | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers. |