CHEMBIO DIAGNOSTICS GMBH · 89-08 · GERMANY
For CHEMBIO DIAGNOSTICS 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 DPP SARS CoV-2 IgM/IgG with DPP Micro Reader II; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 08/31/2021; address is Schwarzschildstr. 1 , Berlin, Berlin GERMANY, verified against its source on 2026-09-16.
- Firm
- CHEMBIO DIAGNOSTICS 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
- Schwarzschildstr. 1 , Berlin, Berlin GERMANY verified
- Date published
- 08/31/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- DPP SARS CoV-2 IgM/IgG with DPP Micro Reader II verified
What the source says
CHEMBIO DIAGNOSTICS GMBH Date Published : 08/31/2021 Schwarzschildstr. 1 , Berlin, Berlin GERMANY 83 Q - - KO Reagent, coronavirus serological Date Published: 08/31/2021 Desc: DPP SARS CoV-2 IgM/IgG with DPP Micro Reader II
— 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.