# BIOHIT HEALTHCARE (HEIFEI) CO LT · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For BIOHIT HEALTHCARE (HEIFEI) CO LT · 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 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 2026-09-16.

- **Firm:** BIOHIT HEALTHCARE (HEIFEI) CO LT _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Bldg D Innovation Pk We , No. 800 Wangjiang West Rd; Shushan , Hefei, Anhui CHINA _(verified: appears in the quote below)_
- **Date published:** 06/22/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay) | SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Hough Covid-19 Home Test _(verified: each item appears in the quote below)_

## 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 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: Hough Covid-19 Home Test

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).