KANGMEI TIANHONG BIOTECH (BEIJING) CO., LTD · 89-08 · CHINA

For KANGMEI TIANHONG BIOTECH (BEIJING) CO., LTD, import alert is 89-08; country is CHINA; 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)"; 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 # 16 , No. 1 Gaolizhang Road , Haidian, CHINA, verified against its source on 2026-09-30.

What the source says

KANGMEI TIANHONG BIOTECH (BEIJING) CO., LTD Date Published : 03/11/2021 # 16 , No. 1 Gaolizhang Road , Haidian, CHINA

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.