GENRUI BIOTECH INC · 89-08 · CHINA
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
- 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
- 4-10f Building 3 Geya T , Shenzhen, CHINA verified
- Date published
- 01/10/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | 2019-nCoV IgM/IgG | Novel Coronavirus (2019- nCoV)IgG/IgMTest Kit(Colloidal gold) each item verified
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)
— 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 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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html