Reference Source

Bosch Healthcare Solutions GmbH · 89-08 · GERMANY

For Bosch Healthcare Solutions 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 Vivalytic VRI | Vivalytic Viral Respiratory tract Infections; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 09/30/2021; address is Stuttgarter Str. 130 , Waiblingen, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-16.

Firm
Bosch Healthcare Solutions 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
Stuttgarter Str. 130 , Waiblingen, Baden-Wurttemberg GERMANY verified
Date published
09/30/2021 verified
Product code
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid each item verified
Product
Vivalytic VRI | Vivalytic Viral Respiratory tract Infections each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Bosch Healthcare Solutions GmbH Date Published : 09/30/2021 Stuttgarter Str. 130 , Waiblingen, Baden-Wurttemberg GERMANY 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: Vivalytic VRI 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: Vivalytic Viral Respiratory tract Infections

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

Source

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