# Corange International Ltd. Hamilton Cham Branch · 89-08 · SWITZERLAND — FDA import alert red lists: firms subject to detention without physical examination

For Corange International Ltd. Hamilton Cham Branch · 89-08 · SWITZERLAND, 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 SWITZERLAND; 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 2026-09-16.

- **Firm:** Corange International Ltd. Hamilton Cham Branch _(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:** SWITZERLAND _(verified: appears in the quote below)_
- **Address:** Hinterbergstrasse 9 , Postfach 5146 , Cham 1, Zug SWITZERLAND _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) _(verified: appears in the quote below)_
- **FDA notes:** Elecsys HBsAg Immunoassay Kits 11/26/1997 _(verified: appears in the quote below)_

## What the source says

> Corange International Ltd. Hamilton Cham Branch Date Published : 09/16/2009 Hinterbergstrasse 9 , Postfach 5146 , Cham 1, Zug SWITZERLAND 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

## 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/).