# Gerbion Gmbh · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Gerbion 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 VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is Remsstr. 1 , Kornwestheim, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-16.

- **Firm:** Gerbion 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:** Remsstr. 1 , Kornwestheim, Baden-Wurttemberg GERMANY _(verified: appears in the quote below)_
- **Date published:** 06/08/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 _(verified: appears in the quote below)_

## What the source says

> Gerbion Gmbh Date Published : 06/08/2022 Remsstr. 1 , Kornwestheim, Baden-Wurttemberg GERMANY 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0

## 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/).