Gerbion Gmbh · 89-08 · GERMANY
For Gerbion 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 VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is Remsstr. 1 , Kornwestheim, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-30.
- Firm
- Gerbion 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
- Remsstr. 1 , Kornwestheim, Baden-Wurttemberg GERMANY verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 verified
What the source says
Gerbion Gmbh Date Published : 06/08/2022 Remsstr. 1 , Kornwestheim, Baden-Wurttemberg 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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0
— 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.