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

For Sacace Biotechnologies · 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 HCV Real TM Quant | HCV Real TM Quant | HBV Real TM Quant | HBV Real TM Quant | HCV Real TM Quant | SARS-CoV-2 Real-TM | StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | AccuraDTect SARS-CoV-2 RT-qPCR Kit; product code is 57 V - - 10 Hepatitis C Virus Encoded Antigen | 81 K - - SJ System For The Identification Of Hepatitis B Antigen | 81 K - - SJ System For The Identification Of Hepatitis B Antigen | 83 M - - KT Hepatitis Viral B DNA Detection | 83 M - - ZP Assay, Hybridization and/or Nucleic Acid Amplification For Detection of Hepatitis C RNA, Hepatitis C | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 04/06/2017; address is Via Giovanni Battista Scalabrini 44 , Como, Como ITALY, verified against its source on 2026-09-16.

- **Firm:** Sacace Biotechnologies _(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 Giovanni Battista Scalabrini 44 , Como, Como ITALY _(verified: appears in the quote below)_
- **Date published:** 04/06/2017 _(verified: appears in the quote below)_
- **Product code:** 57 V - - 10 Hepatitis C Virus Encoded Antigen | 81 K - - SJ System For The Identification Of Hepatitis B Antigen | 81 K - - SJ System For The Identification Of Hepatitis B Antigen | 83 M - - KT Hepatitis Viral B DNA Detection | 83 M - - ZP Assay, Hybridization and/or Nucleic Acid Amplification For Detection of Hepatitis C RNA, Hepatitis C | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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:** HCV Real TM Quant | HCV Real TM Quant | HBV Real TM Quant | HBV Real TM Quant | HCV Real TM Quant | SARS-CoV-2 Real-TM | StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | AccuraDTect SARS-CoV-2 RT-qPCR Kit _(verified: each item appears in the quote below)_
- **FDA notes:** Class III device without a PMA approval | Class III device without a PMA approval | Class III device without a PMA approval | Class III device without a PMA approval | Class III device without a PMA approval _(verified: each item appears in the quote below)_

## What the source says

> Sacace Biotechnologies Date Published : 04/06/2017 Via Giovanni Battista Scalabrini 44 , Como, Como ITALY 57 V - - 10 Hepatitis C Virus Encoded Antigen Date Published: 04/06/2017 Desc: HCV Real TM Quant Notes: Class III device without a PMA approval 81 K - - SJ System For The Identification Of Hepatitis B Antigen Date Published: 04/06/2017 Desc: HCV Real TM Quant Notes: Class III device without a PMA approval 81 K - - SJ System For The Identification Of Hepatitis B Antigen Date Published: 04/06/2017 Desc: HBV Real TM Quant Notes: Class III device without a PMA approval 83 M - - KT Hepatitis Viral B DNA Detection Date Published: 04/06/2017 Desc: HBV Real TM Quant Notes: Class III device without a PMA approval 83 M - - ZP Assay, Hybridization and/or Nucleic Acid Amplification For Detection of Hepatitis C RNA, Hepatitis C Date Published: 04/06/2017 Desc: HCV Real TM Quant Notes: Class III device without a PMA approval 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: SARS-CoV-2 Real-TM 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit

## 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/).