BIOHIT HEALTHCARE (HEIFEI) CO LT · 89-08 · CHINA
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
- 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
- Address
- Bldg D Innovation Pk We , No. 800 Wangjiang West Rd; Shushan , Hefei, Anhui CHINA verified
- Date published
- 06/22/2021 verified
- 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. each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html