# Sentinel CH SpA · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For Sentinel CH SpA · 89-08 · ITALY, 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 ITALY; 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 2026-09-16.

- **Firm:** Sentinel CH SpA _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Via Robert Koch 2 , Milan, Milan ITALY _(verified: appears in the quote below)_
- **Date published:** 12/03/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: each item appears in the quote below)_
- **Product:** STAT-NAT COVID-19 MULTI | STAT-NAT COVID-19 Positive Control _(verified: each item appears in the quote below)_

## What the source says

> Sentinel CH SpA Date Published : 12/03/2021 Via Robert Koch 2 , Milan, Milan ITALY 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).