Nanjing Norman Biological Technology Co., Ltd · 89-08 · CHINA
For Nanjing Norman Biological Technology 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 Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold) | Novel Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 12/23/2020; address is No. 197 Pharmaceutical Valley Road , Jiangbei New Area , Nanjing, Jiangsu CHINA, verified against its source on 2026-09-16.
- Firm
- Nanjing Norman Biological Technology 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
- No. 197 Pharmaceutical Valley Road , Jiangbei New Area , Nanjing, Jiangsu CHINA verified
- Date published
- 12/23/2020 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold) | Novel Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold) each item verified
What the source says
Nanjing Norman Biological Technology Co., Ltd Date Published : 12/23/2020 No. 197 Pharmaceutical Valley Road , Jiangbei New Area , Nanjing, Jiangsu CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 12/23/2020 Desc: Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 01/11/2021 Desc: Novel Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html