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

For DIAGNOSTIC SRL · 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 code is 75 - - - -- Chemistry | 81 - - - -- Hematology | 82 - - - -- Immunology | 83 - - - -- Microbiology | 88 - - - -- Pathology | 91 - - - -- Toxicology | 92 - - - -- Molecular Genetics; date published is 06/07/2018; address is Largo Ferrandina 10 , Naples, Naples ITALY, verified against its source on 2026-09-16.

- **Firm:** DIAGNOSTIC SRL _(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:** Largo Ferrandina 10 , Naples, Naples ITALY _(verified: appears in the quote below)_
- **Date published:** 06/07/2018 _(verified: appears in the quote below)_
- **Product code:** 75 - - - -- Chemistry | 81 - - - -- Hematology | 82 - - - -- Immunology | 83 - - - -- Microbiology | 88 - - - -- Pathology | 91 - - - -- Toxicology | 92 - - - -- Molecular Genetics _(verified: each item appears in the quote below)_
- **FDA notes:** In vitro diagnostic products | In vitro diagnostic products | In vitro diagnostic products | In vitro diagnostic products | In vitro diagnostic products | In vitro diagnostic products | In vitro diagnostic products _(verified: each item appears in the quote below)_

## What the source says

> DIAGNOSTIC SRL Date Published : 06/07/2018 Largo Ferrandina 10 , Naples, Naples ITALY 75 - - - -- Chemistry Date Published: 06/07/2018 Notes: In vitro diagnostic products 81 - - - -- Hematology Date Published: 06/07/2018 Notes: In vitro diagnostic products 82 - - - -- Immunology Date Published: 06/07/2018 Notes: In vitro diagnostic products 83 - - - -- Microbiology Date Published: 06/07/2018 Notes: In vitro diagnostic products 88 - - - -- Pathology Date Published: 06/07/2018 Notes: In vitro diagnostic products 91 - - - -- Toxicology Date Published: 06/07/2018 Notes: In vitro diagnostic products 92 - - - -- Molecular Genetics Date Published: 06/07/2018 Notes: In vitro diagnostic products

## 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/).