Swisstronics Contract Manufacturing AG · 89-08 · SWITZERLAND
For Swisstronics Contract Manufacturing AG, 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 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 2026-09-30.
- 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
What the source says
Swisstronics Contract Manufacturing AG Date Published : 01/26/2021 Gebenloostrasse 15 , Bronschhofen, Saint Gall 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 Product
83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: The Bloom Lab
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.