Beijing Genesee Biotech, Inc. · 89-08 · CHINA
For Beijing Genesee Biotech, Inc., 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 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 2026-09-30.
- Firm
- Beijing Genesee Biotech, Inc. 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
- No. 36, Yanqi Donger Road , Huairou Yanqi Industrial Dev Zn , Beijing, CHINA verified
- Date published
- 02/20/2018 verified
- Product code
- 83 J - - SY Kit, Identification, Mycobacteria | 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) each item verified
- Product
- Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit | Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit each item verified
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
— 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.
Product code and Product
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:
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html