ZHENGZHOU FORTUNE BIOSCIENCE CO. Ltd · 89-08 · CHINA
For ZHENGZHOU FORTUNE BIOSCIENCE 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 COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 IgG Antibody Rapid Test Kit | COVID-19 IgM Antibody Rapid Test Kit | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 IgG Antibody Rapid Test Kit | COVID-19 IgM Antibody Rapid Test Kit | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 IgM Antibody Rapid Test Kit | COVID-19 IgG Antibody Rapid Test Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2020; address is East Wansan Road , Shangdou Da Street; Zhongmouxian , Zhengzhou, Henan CHINA, verified against its source on 2026-09-30.
- Firm
- ZHENGZHOU FORTUNE BIOSCIENCE 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
- East Wansan Road , Shangdou Da Street; Zhongmouxian , Zhengzhou, Henan CHINA verified
- Date published
- 06/22/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 IgG Antibody Rapid Test Kit | COVID-19 IgM Antibody Rapid Test Kit | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 IgG Antibody Rapid Test Kit | COVID-19 IgM Antibody Rapid Test Kit | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 IgM Antibody Rapid Test Kit | COVID-19 IgG Antibody Rapid Test Kit each item verified
What the source says
ZHENGZHOU FORTUNE BIOSCIENCE CO. Ltd Date Published : 06/22/2020 East Wansan Road , Shangdou Da Street; Zhongmouxian , Zhengzhou, Henan CHINA
— accessdata.fda.gov, retrieved 2026-09-22
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.
Product code and Product
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: COVID-19 IgG Antibody Rapid Test Kit 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: COVID-19 IgM Antibody Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: COVID-19 IgG Antibody Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: COVID-19 IgM Antibody Rapid Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: COVID-19 IgM Antibody Rapid Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: COVID-19 IgG Antibody Rapid Test Kit
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html