Sacace Biotechnologies · 89-08 · ITALY

For Sacace Biotechnologies, 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 HCV Real TM Quant | HBV Real TM Quant | HCV Real TM Quant | HBV Real TM Quant | HCV Real TM Quant | StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | SARS-CoV-2 Real-TM | 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 2026-09-30.

What the source says

Sacace Biotechnologies Date Published : 04/06/2017 Via Giovanni Battista Scalabrini 44 , Como, Como ITALY

— accessdata.fda.gov, retrieved 2026-09-22

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.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.