BIOHIT HEALTHCARE (HEIFEI) CO LT · 89-08 · CHINA

For BIOHIT HEALTHCARE (HEIFEI) CO LT, 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 Quantitative Assay Kit (Enzyme-linked Immunoassay) | SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Hough Covid-19 Home Test; product code is 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 06/22/2021; address is Bldg D Innovation Pk We , No. 800 Wangjiang West Rd; Shushan , Hefei, Anhui CHINA, verified against its source on 2026-09-30.

What the source says

BIOHIT HEALTHCARE (HEIFEI) CO LT Date Published : 06/22/2021 Bldg D Innovation Pk We , No. 800 Wangjiang West Rd; Shushan , Hefei, Anhui CHINA

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

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 2026-09-15

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.