Xiamen Biotime Biotechnology Company · 89-08 · CHINA

For Xiamen Biotime Biotechnology Company, 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 SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST | SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST | INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test | Innova COVID-19 Self-Test kit | BIOTIME SARS-CoV-2 Antigen Rapid Qualitative Test; product code is 83 L - - IB Device, General Purpose, Microbiology, Diagnostic | 83 Q - - KP Coronavirus antigen detection test system. | 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 03/02/2021; address is F 2 F 3 , 4f Pingcheng South Road, Haicang Street; Haicang District , Xiamen, Fujian CHINA, verified against its source on 2026-09-30.

What the source says

Xiamen Biotime Biotechnology Company Date Published : 03/02/2021 F 2 F 3 , 4f Pingcheng South Road, Haicang Street; Haicang District , Xiamen, Fujian 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.