Reference Source

Senova Gmbh · 89-08 · GERMANY

For Senova Gmbh · 89-08 · GERMANY, 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 GERMANY; product is Bloom COVID-19 Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Winzerlaer Str. 2a , Jena, Thuringia GERMANY, verified against its source on 2026-09-16.

Firm
Senova Gmbh 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
GERMANY verified
Address
Winzerlaer Str. 2a , Jena, Thuringia GERMANY verified
Date published
01/26/2021 verified
Product code
83 Q - - KO Reagent, coronavirus serological verified
Product
Bloom COVID-19 Test verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Senova Gmbh Date Published : 01/26/2021 Winzerlaer Str. 2a , Jena, Thuringia GERMANY 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Bloom COVID-19 Test

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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