Beijing Genesee Biotech, Inc. · 89-08 · CHINA
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
- 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 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:
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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