Reference Source

Swisstronics Contract Manufacturing AG · 89-08 · SWITZERLAND

For Swisstronics Contract Manufacturing AG · 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 is The Bloom Lab; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Gebenloostrasse 15 , Bronschhofen, Saint Gall SWITZERLAND, verified against its source on 2026-09-16.

Firm
Swisstronics Contract Manufacturing AG 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
Gebenloostrasse 15 , Bronschhofen, Saint Gall SWITZERLAND verified
Date published
01/26/2021 verified
Product code
83 Q - - KO Reagent, coronavirus serological verified
Product
The Bloom Lab verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Swisstronics Contract Manufacturing AG Date Published : 01/26/2021 Gebenloostrasse 15 , Bronschhofen, Saint Gall SWITZERLAND 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: The Bloom Lab

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

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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