ZHEJIANG GENE SCIENCE CO., LTD · 89-08 · CHINA
For ZHEJIANG GENE SCIENCE 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 Novel Coronavirus (2019nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography) | Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is No. 2 Workshop, Pharmaceutical Industrial Park, No. 11 Shengxing Road, Shangyu Economic And Technological Dev , Shaoxing, Zhejiang CHINA, verified against its source on 2026-09-16.
- Firm
- ZHEJIANG GENE SCIENCE 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. 2 Workshop, Pharmaceutical Industrial Park, No. 11 Shengxing Road, Shangyu Economic And Technological Dev , Shaoxing, Zhejiang CHINA verified
- Date published
- 06/22/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Novel Coronavirus (2019nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography) | Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography) each item verified
What the source says
ZHEJIANG GENE SCIENCE CO., LTD Date Published : 06/22/2021 No. 2 Workshop, Pharmaceutical Industrial Park, No. 11 Shengxing Road, Shangyu Economic And Technological Dev , Shaoxing, Zhejiang CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 04/19/2022 Desc: Novel Coronavirus (2019nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html