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WONDFO USA CO., LTD.

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 630-468-2199
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007606081
DUNS Number: 849098897

Catalogue (417)

Page 5 of 9

Device	Model / Reference	Registries	Class	Status
Wondfo Drug Test Dip Card	WDOA-4104	FDA UDI	Class II	Active
Preview	PRE-HCG-25SE-CLIA	FDA UDI	Class II	Active
T-Square	QODOA-666EUO-I	FDA UDI	Class II	Active
Prime Screen	DTDOA-6125-2BX-A	FDA UDI	Class II	Active
Preview	PRE-WDOA-6125	FDA UDI	Class II	Active
WELLlife™	WDFT-201-POC1W-25BX	FDA UDI	Class II	Active
T-Cup	TDOA-4104	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WD-11MT	FDA UDI	Class II	Active
WELLlife™	WCOVFLU-OTC-25	FDA UDI	Class II	Active
T-Square	QODOA-496NTEUO-I	FDA UDI	Class II	Active
Prime Screen	DQODOA-256EUO-I-5BX-A	FDA UDI	Class II	Active
Wondfo	SODOA-166EUO	FDA UDI	Class II	Active
Preview	PRE-WDOA-274	FDA UDI	Class II	Active
Wondfo	SW1-C	FDA UDI	Class II	Active
Wondfo	WDTH-101-25B	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-565	FDA UDI	Class II	Active
T-Cup	TDOA-8104	FDA UDI	Class II	Active
T-Cup Compact	CDOA-L6125	FDA UDI	Class II	Active
T-Cup	TDOA-264	FDA UDI	Class II	Active
T-Cube	ODOA-856EUO	FDA UDI	U	Active
T-Square	QODOA-366EUO-I	FDA UDI	Class II	Active
Preview	PRE-HCG-OTC-10-3BX-CA	FDA UDI	Class II	Active
T-Cup	TDOA-6124	FDA UDI	Class II	Active
Wondfo	WS-H20L50B	FDA UDI	Class II	Active
HORMONElife™	W52-S-SQ-6BX	FDA UDI	Class I	Active
Wondfo Drug Test Dip Card	WDMD-114	FDA UDI	Class II	Active
Wondfo	DW1-M	FDA UDI	Class II	Active
Wondfo Key Cup	KDOA-274	FDA UDI	Class II	Active
SAFElife™	WFTY-OTC1-5BX	FDA UDI	Class II	Active
T-Cup	TDOA-654	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDPC-114	FDA UDI	U	Active
Wondfo Pregnancy Test	W1-MII	FDA UDI	Class II	Active
Prime Screen	DWDOP-114-25BX-A	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDCO-114	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDMT-114	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDMO-114	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDBZ-114	FDA UDI	Class II	Active
T-Cup	TDOA-6125A3	FDA UDI	Class II	Active
WELLlife™	WCOVFLU-POC-25	FDA UDI	Class II	Active
Wondfo Pregnancy Test	W1-C	FDA UDI	Class II	Active
SAFElife™	WFTY-OTC1-1BX	FDA UDI	Class II	Active
SAFElife™	WDFT-201-OTC1-10BX	FDA UDI	Class II	Active
Wondfo	WS-H10L25	FDA UDI	Class II	Active
Wondfo	DW2-S	FDA UDI	Class I	Active
T-Cup	TDOA-3135	FDA UDI	Class II	Active
Preview	PRE-STA-25	FDA UDI	Class I	Active
WELLlife™	WV01P0002	FDA UDI	N	Active
WELLlife™	WCOVFLU-OTC-5	FDA UDI	Class II	Active
T-Cup	TDOA-4124	FDA UDI	Class II	Active
T-Cup	TDOA-254A3	FDA UDI	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.