Sentinel CH SpA · 89-08 · ITALY
For Sentinel CH SpA, 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 STAT-NAT COVID-19 MULTI | STAT-NAT COVID-19 Positive Control; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 12/03/2021; address is Via Robert Koch 2 , Milan, Milan ITALY, verified against its source on 2026-09-30.
- Firm
- Sentinel CH SpA 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
- Via Robert Koch 2 , Milan, Milan ITALY verified
- Date published
- 12/03/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid each item verified
- Product
- STAT-NAT COVID-19 MULTI | STAT-NAT COVID-19 Positive Control each item verified
What the source says
Sentinel CH SpA Date Published : 12/03/2021 Via Robert Koch 2 , 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: 12/03/2021 Desc: STAT-NAT COVID-19 MULTI 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 12/03/2021 Desc: STAT-NAT COVID-19 Positive Control
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html