Corange International Ltd. Hamilton Cham Branch · 89-08 · SWITZERLAND
For Corange International Ltd. Hamilton Cham Branch, import alert is 89-08; country is SWITZERLAND; 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 code is 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); date published is 09/16/2009; address is Hinterbergstrasse 9 , Postfach 5146 , Cham 1, Zug SWITZERLAND, verified against its source on 2026-09-30.
- Firm
- Corange International Ltd. Hamilton Cham Branch 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
- SWITZERLAND verified
- Address
- Hinterbergstrasse 9 , Postfach 5146 , Cham 1, Zug SWITZERLAND verified
- Date published
- 09/16/2009 verified
- Product code
- 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) verified
- FDA notes
- Elecsys HBsAg Immunoassay Kits 11/26/1997 verified
What the source says
Corange International Ltd. Hamilton Cham Branch Date Published : 09/16/2009 Hinterbergstrasse 9 , Postfach 5146 , Cham 1, Zug SWITZERLAND
— 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 FDA notes
83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Date Published: 09/16/2009 Notes: Elecsys HBsAg Immunoassay Kits 11/26/1997
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html