Anhui Deepblue Medical Technology Co Ltd · 89-08 · CHINA

For Anhui Deepblue Medical 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 Immune Colloidal Gold Lateral Flow Strip for IgG & IgM of SARS-CoV-2 | COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) | COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 05/04/2021; address is No. 777 Jimingshan Road, High-Tech Development Zone , Hefei, Anhui CHINA, verified against its source on 2026-09-16.

What the source says

Anhui Deepblue Medical Technology Co Ltd Date Published : 05/04/2021 No. 777 Jimingshan Road, High-Tech Development Zone , Hefei, Anhui CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 05/04/2021 Desc: Immune Colloidal Gold Lateral Flow Strip for IgG & IgM of SARS-CoV-2 83 Q - - KO Reagent, coronavirus serological Date Published: 05/04/2021 Desc: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/04/2021 Desc: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

— accessdata.fda.gov, retrieved 2026-09-15

Source

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

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.