QIAGEN LAKE CONSTANCE GMBH · 89-08 · GERMANY
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
- 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
- Bodenseeallee 20 , Stockach, GERMANY verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- ENTV-Dx LFR reader verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.