Bosch Healthcare Solutions GmbH · 89-08 · GERMANY
For Bosch Healthcare Solutions GmbH, import alert is 89-08; country is GERMANY; 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 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 2026-09-30.
- 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
What the source says
Bosch Healthcare Solutions GmbH Date Published : 09/30/2021 Stuttgarter Str. 130 , Waiblingen, Baden-Wurttemberg GERMANY
— 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 - - 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html