Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Wondfo BiotechLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Wondfo USA with 5 device recalls and 2 510(k) clearances. The most recent is a 510(k) clearance dated Aug 20, 2025: WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 20, 2025 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestK251563 · SCA | 510(k) clearances |
| Jan 16, 2025 | WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTestK243256 · SCA | 510(k) clearances |
| Apr 22, 2024 | Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10Class II · Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this d | Device recalls |
| Apr 22, 2024 | Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) CClass II · Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this d | Device recalls |
| Apr 22, 2024 | Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One SClass II · Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this d | Device recalls |
| Apr 22, 2024 | Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo Class II · Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this d | Device recalls |
| Apr 22, 2024 | Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, ParClass II · Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this d | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
