WUHAN EASYDIAGNOSIS BIOMEDICINE CO Ltd · 89-08 · CHINA
For WUHAN EASYDIAGNOSIS BIOMEDICINE CO Ltd · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; 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 2026-09-16.
- Firm
- WUHAN EASYDIAGNOSIS BIOMEDICINE CO Ltd verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- 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
- Date published
- 07/17/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- 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 each item verified
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 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html