QIAGEN LAKE CONSTANCE GMBH · 89-08 · GERMANY
For QIAGEN LAKE CONSTANCE 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 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 2026-09-30.
- 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
— 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 - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: ENTV-Dx LFR reader
— all from 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.