# Beijing Genesee Biotech, Inc. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Beijing Genesee Biotech, Inc. · 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 Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit | Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit; product code is 83 J - - SY Kit, Identification, Mycobacteria | 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); date published is 02/20/2018; address is No. 36, Yanqi Donger Road , Huairou Yanqi Industrial Dev Zn , Beijing, CHINA, verified against its source on 2026-09-16.

- **Firm:** Beijing Genesee Biotech, Inc. _(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:** No. 36, Yanqi Donger Road , Huairou Yanqi Industrial Dev Zn , Beijing, CHINA _(verified: appears in the quote below)_
- **Date published:** 02/20/2018 _(verified: appears in the quote below)_
- **Product code:** 83 J - - SY Kit, Identification, Mycobacteria | 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) _(verified: each item appears in the quote below)_
- **Product:** Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit | Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit _(verified: each item appears in the quote below)_

## What the source says

> Beijing Genesee Biotech, Inc. Date Published : 02/20/2018 No. 36, Yanqi Donger Road , Huairou Yanqi Industrial Dev Zn , Beijing, CHINA 83 J - - SY Kit, Identification, Mycobacteria Date Published: 02/20/2018 Desc: Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit Notes: 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Date Published: 02/20/2018 Desc: Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit Notes:

## 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/).