BEIJING DIAGREAT BIOTECHNOLOGIES Co Ltd · 89-08 · CHINA
For BEIJING DIAGREAT BIOTECHNOLOGIES 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 2019-nCoV IgG Antibody Determination Kit | 2019-nCoV IgM A | 2019-nCOV IgG/IgM Antibody Rapid Test Kit | 2019-nCOV IgG/IgM Antibody Rapid Test Kit | 2019-nCoV IgG Antibody Determination Kit | 2019-nCoV IgM A | 2019-nCoV IgG Antibody Determination Kit | 2019-nCoV IgM A | 2019-nCOV IgG/IgM 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 09/02/2020; address is Xinhualian Science And Technology Building 3rd Floor , 5 Jaichuang Rd , Beijing, Beijing CHINA, verified against its source on 2026-09-16.
- Firm
- BEIJING DIAGREAT BIOTECHNOLOGIES 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
- Xinhualian Science And Technology Building 3rd Floor , 5 Jaichuang Rd , Beijing, Beijing CHINA verified
- Date published
- 09/02/2020 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
- 2019-nCoV IgG Antibody Determination Kit | 2019-nCoV IgM A | 2019-nCOV IgG/IgM Antibody Rapid Test Kit | 2019-nCOV IgG/IgM Antibody Rapid Test Kit | 2019-nCoV IgG Antibody Determination Kit | 2019-nCoV IgM A | 2019-nCoV IgG Antibody Determination Kit | 2019-nCoV IgM A | 2019-nCOV IgG/IgM Antibody Rapid Test Kit each item verified
What the source says
BEIJING DIAGREAT BIOTECHNOLOGIES Co Ltd Date Published : 09/02/2020 Xinhualian Science And Technology Building 3rd Floor , 5 Jaichuang Rd , Beijing, Beijing CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/02/2020 Desc: 2019-nCoV IgG Antibody Determination Kit 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/02/2020 Desc: 2019-nCoV IgM A 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/02/2020 Desc: 2019-nCOV IgG/IgM Antibody Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 09/02/2020 Desc: 2019-nCOV IgG/IgM Antibody Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 09/02/2020 Desc: 2019-nCoV IgG Antibody Determination Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 09/02/2020 Desc: 2019-nCoV IgM A 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/02/2020 Desc: 2019-nCoV IgG Antibody Determination Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/02/2020 Desc: 2019-nCoV IgM A 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/02/2020 Desc: 2019-nCOV IgG/IgM Antibody Rapid Test Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html