# QIAGEN LAKE CONSTANCE GMBH · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For QIAGEN LAKE CONSTANCE 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 ENTV-Dx LFR reader; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is Bodenseeallee 20 , Stockach, GERMANY, verified against its source on 2026-09-16.

- **Firm:** QIAGEN LAKE CONSTANCE 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:** Bodenseeallee 20 , Stockach, GERMANY _(verified: appears in the quote below)_
- **Date published:** 07/27/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** ENTV-Dx LFR reader _(verified: appears in the quote below)_

## What the source says

> QIAGEN LAKE CONSTANCE GMBH Date Published : 07/27/2021 Bodenseeallee 20 , Stockach, GERMANY 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: ENTV-Dx LFR reader

## 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/).