Reference Source

Corange International Ltd. Hamilton Cham Branch · 89-08 · SWITZERLAND

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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