GENRUI BIOTECH INC · 89-08 · CHINA

For GENRUI BIOTECH INC, 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 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | 2019-nCoV IgM/IgG | Novel Coronavirus (2019- nCoV)IgG/IgMTest Kit(Colloidal gold); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is listed twice: 01/10/2022 and 04/15/2021; address is listed twice: 4-10f Building 3 Geya T , Shenzhen, CHINA and B , 1183 Liuxiandadao Liuxian Dasha; Nanshanblvd , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.

What the source says

GENRUI BIOTECH INC Date Published : 01/10/2022 4-10f Building 3 Geya T , Shenzhen, 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

The same source also states

Genrui Biotech Inc Date Published : 04/15/2021 B , 1183 Liuxiandadao Liuxian Dasha; Nanshanblvd , Shenzhen, Guangdong CHINA

— 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.