# GENRUI BIOTECH INC · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For GENRUI BIOTECH INC · 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 (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 01/10/2022; address is 4-10f Building 3 Geya T , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** GENRUI BIOTECH INC _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 4-10f Building 3 Geya T , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 01/10/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | 2019-nCoV IgM/IgG | Novel Coronavirus (2019- nCoV)IgG/IgMTest Kit(Colloidal gold) _(verified: each item appears in the quote below)_

## What the source says

> GENRUI BIOTECH INC Date Published : 01/10/2022 4-10f Building 3 Geya T , Shenzhen, CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/10/2022 Desc: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) 83 Q - - KO Reagent, coronavirus serological Date Published: 01/10/2022 Desc: 2019-nCoV IgM/IgG 83 Q - - KO Reagent, coronavirus serological Date Published: 01/10/2022 Desc: Novel Coronavirus (2019- nCoV)IgG/IgMTest Kit(Colloidal gold)

## The same source also states

> Genrui Biotech Inc Date Published : 04/15/2021 B , 1183 Liuxiandadao Liuxian Dasha; Nanshanblvd , Shenzhen, Guangdong CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/10/2022 Desc: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) 83 Q - - KO Reagent, coronavirus serological Date Published: 04/15/2021 Desc: 2019-nCoV IgM/IgG 83 Q - - KO Reagent, coronavirus serological Date Published: 04/15/2021 Desc: Novel Coronavirus(2019-nCoV)IgG/IgM Test Kit(Colloidal gold)

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).