# Bosch Healthcare Solutions GmbH · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Stuttgarter Str. 130 , Waiblingen, Baden-Wurttemberg GERMANY _(verified: appears in the quote below)_
- **Date published:** 09/30/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: each item appears in the quote below)_
- **Product:** Vivalytic VRI | Vivalytic Viral Respiratory tract Infections _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).