CHEMBIO DIAGNOSTICS GMBH · 89-08 · GERMANY
For CHEMBIO DIAGNOSTICS 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 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 2026-09-30.
- 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
— 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 - - KO Reagent, coronavirus serological Date Published: 08/31/2021 Desc: DPP SARS CoV-2 IgM/IgG with DPP Micro Reader II
— 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.