ZHENGZHOU FORTUNE BIOSCIENCE CO. Ltd · 89-08 · CHINA
For ZHENGZHOU FORTUNE BIOSCIENCE 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 COVID-19 IgM Antibody Rapid Test Kit | COVID-19 IgG Antibody Rapid Test Kit | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 IgM Antibody Rapid Test Kit | 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; 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 2026-09-16.
- 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 IgM Antibody Rapid Test Kit | COVID-19 IgG Antibody Rapid Test Kit | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | COVID-19 IgM Antibody Rapid Test Kit | 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 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 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: COVID-19 IgM Antibody Rapid Test Kit 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 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) 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 IgM Antibody Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: COVID-19 IgG Antibody Rapid Test Kit 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 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: COVID-19 IgG Antibody Rapid Test Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html