Facility

Wondfo USA Co., Ltd.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3016252795
Establishment type	Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	6720 Cobra Way San Diego, CA, US 92121
Registration status	Active · expires 2026
Parent company	Wondfo USA Co., Ltd. (owner-operator 10028951)
Brand names	Clarity COVID-19 / Influenza A&B Antigen Test; WELLlife COVID-19 / Influenza A&B Antigen Test; INDICAID COVID-19 / INFLUENZA A&B ANTIGEN TEST; 2San 3 in 1 COVID-19 + Flu A&B Rapid Self-Test; WELLlife COVID-19 / Flu A&B Home Test; WELLlife COVID-19 / Influenza A&B Antigen Test with Control Kit (WELLlife COVID-19 / Influenza A&B Antigen Test); Dealmed COVID-19 / Influenza A&B Antigen Test; QuickVue Influenza+SARS Test; INDICAID COVID-19 / Flu A&B Home Test

Activity by year

Recalls (1)

Devices registered here (1)

Multi-Analyte Respiratory Virus Antigen Detection Test
Product code SCA (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3987

Recalls & enforcement

Class IIOngoing2024-04-22
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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Wondfo USA Co., Ltd. (FEI 3016252795) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016252795-wondfo-usa-co-ltd/

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