WUHAN EASYDIAGNOSIS BIOMEDICINE CO Ltd · 89-08 · CHINA

For WUHAN EASYDIAGNOSIS BIOMEDICINE CO Ltd, import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test | Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test | Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/17/2020; address is No.388, Gaoxin 2nd RD, East Lake HiTech Development Zone , Room 3 & 4, 2nd Floor, Bldg 25, Phase 3.1 Wuhan Optics Valley International Biopharmaceutical Enterprise Accel , Wuhan, Hubei CHINA, verified against its source on 2026-09-30.

What the source says

WUHAN EASYDIAGNOSIS BIOMEDICINE CO Ltd Date Published : 07/17/2020 No.388, Gaoxin 2nd RD, East Lake HiTech Development Zone , Room 3 & 4, 2nd Floor, Bldg 25, Phase 3.1 Wuhan Optics Valley International Biopharmaceutical Enterprise Accel , Wuhan, Hubei CHINA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.