Hyris S.R.L. · 89-08 · ITALY
For Hyris S.R.L., import alert is 89-08; country is ITALY; 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 bKIT Virus Finder COVID-19; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is Corso Giuseppe Garibaldi 60 , Milan, Milan ITALY, verified against its source on 2026-09-30.
- Firm
- Hyris S.R.L. 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
- ITALY verified
- Address
- Corso Giuseppe Garibaldi 60 , Milan, Milan ITALY verified
- Date published
- 11/24/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- bKIT Virus Finder COVID-19 verified
What the source says
Hyris S.R.L. Date Published : 11/24/2021 Corso Giuseppe Garibaldi 60 , Milan, Milan ITALY
— 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: 11/24/2021 Desc: bKIT Virus Finder COVID-19
— 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.