KANGMEI TIANHONG BIOTECH BEIJING · 89-08 · CHINA
For KANGMEI TIANHONG BIOTECH BEIJING · 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 Novir Insta COVID-19 Antibody Test | Novir COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) | Novir COVID-19 SARS-CoV2 IgM/IgG Antibody rapid test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is Hongxing Lou 16 , No 1 Courty , Beijing, Beijing CHINA, verified against its source on 2026-09-16.
- Firm
- KANGMEI TIANHONG BIOTECH BEIJING 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
- Hongxing Lou 16 , No 1 Courty , Beijing, Beijing CHINA verified
- Date published
- 03/11/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Novir Insta COVID-19 Antibody Test | Novir COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) | Novir COVID-19 SARS-CoV2 IgM/IgG Antibody rapid test each item verified
What the source says
KANGMEI TIANHONG BIOTECH BEIJING Date Published : 03/11/2021 Hongxing Lou 16 , No 1 Courty , Beijing, Beijing CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: Novir Insta COVID-19 Antibody Test 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: Novir COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: Novir COVID-19 SARS-CoV2 IgM/IgG Antibody rapid test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html