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Data / Medical devices / Italy / DiaSorin Italia S.p.A.

DiaSorin Italia S.p.A.: FDA-registered device maker in SALUGGIA Vercelli, Italy, 28 510(k) clearances and 14 PMA approvals

DiaSorin Italia S.p.A. is registered with the FDA (registration 9610240) in SALUGGIA Vercelli, Italy. It lists 42 device types. The FDA files 28 510(k) clearances and 14 PMA approvals under its listings, the newest dated May 7, 2026. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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FDA registration number
9610240
FEI number
3002808212
Address
VIA CRESCENTINO, snc, SALUGGIA Vercelli, Italy, 13040
Owner or operator
DiaSorin Inc. (9051149)
Roles
Manufacturer, Specification developer
First device listed
March 15, 1979
Registered through
2027
Brand names listed
ETI-AB-AUK-3, ETI-AB-AUK-3 Negative Control, ETI-AB-DELTAk2, ETI-AB-EBK PLUS, ETI-EBK PLUS, ETI-MAX 3000 (TM) Analyzer Operating Software, ETI-MAX 3000TM Analyzer, HUMAN GROWTH HORMONE and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufacturer, Specification developeraccessdata.fda.gov
Analyzer, Chemistry, Micro, For Clinical UseJJF1Manufacturer, Specification developeraccessdata.fda.gov
Antigen, Inflammatory Response Marker, SepsisNTM2Manufactureraccessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C VirusMZO2Manufacturer, Specification developeraccessdata.fda.gov
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 IggMYL3Manufactureraccessdata.fda.gov
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 IgmMYM3Manufactureraccessdata.fda.gov
Coronavirus Antigen Detection Test System.QKPNManufactureraccessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensPMT2Manufactureraccessdata.fda.gov
Device To Detect Antibodies To Hepatitis D VirusSGW2Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, CytomegalovirusLFZ2Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mumps VirusLJY1Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RubellaLFX2Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubeola IggLJB1Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD2Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Varicella-ZosterLFY2Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema PallidumLIP2Manufactureraccessdata.fda.gov
Epstein-Barr Virus, OtherLSE1Manufactureraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Manufactureraccessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)LOL2Manufacturer, Specification developeraccessdata.fda.gov
Procalcitonin AssayPRI2Manufactureraccessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody AssaysSEI2Manufactureraccessdata.fda.gov
Radioimmunoassay, Angiotensin I And ReninCIB2Manufactureraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Manufactureraccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Manufactureraccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Manufactureraccessdata.fda.gov
Radioimmunoassay, Human Growth HormoneCFL1Manufacturer, Specification developeraccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Manufactureraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Manufactureraccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Manufactureraccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONManufactureraccessdata.fda.gov
Reagents, Specific, AnalyteMVU1Manufactureraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Manufactureraccessdata.fda.gov
Research Use Only/Immunology DevicesOTRNSpecification developeraccessdata.fda.gov
Research Use Only/MicrobiologyOTTNManufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufactureraccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Manufactureraccessdata.fda.gov
Test, Antigen, Nuclear, Epstein-Barr VirusLLM1Manufactureraccessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2Manufacturer, Specification developeraccessdata.fda.gov
Test, Hiv DetectionMZF2Manufactureraccessdata.fda.gov
Test, Immunity, Cell Mediated, Mycobacterium TuberculosisNCD3Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 23, 2025DEN250032LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)SGWUnknownDiaSorin, Inc.accessdata.fda.gov
October 27, 2023K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFYSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
September 14, 2021K193650LIAISON FerritinDBFSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
March 2, 2020K193532LIAISON Anti-HAV AssayLOLSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
February 27, 2018K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersPRISubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
January 6, 2017K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetLFZSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
January 5, 2017K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetLSESubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
January 4, 2017K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSESubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
August 25, 2016K160650LIAISON HAV IgM, LIAISON Control HAV IgMLOLSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
June 30, 2016K161526LIAISON CMV IgM Serum Control SetJJXSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
June 30, 2016K161522LIAISON EBV IgM Serum Control SetJJXSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
July 25, 2014K141116LIAISON XL ANALYZERLOLSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
September 6, 2013K131037LIAISON XL HCGDHASubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
August 28, 2013K132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IILGDSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
August 9, 2013K131441LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM IILGDSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
April 5, 2013K130469LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3JLWSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
April 4, 2013K121951LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3CECSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
January 1, 2013K121944LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTCIBSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
September 6, 2012K122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMLFXSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
January 21, 2011K103529LIAISON XL ANALYZER MODEL 10050LOLSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
October 29, 2010K1023143M INTEGRATED CYCLER (110V) & (220V)OOISubstantially EquivalentFocus Diagnostics, Inc.accessdata.fda.gov
December 5, 2008K082049LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAVLOLSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
November 21, 2008K073390DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLSLFXSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
October 18, 2006K060204LIAISON EA IGGLSESubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
July 31, 2006K061247DIASORIN LIAISON TREPONEMA ASSAYLIPSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
March 31, 2006K052794ETI-MAX 3000JJFSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
June 1, 2005K040290DIASORIN LIAISON CMV IGM/IGGLFZSubstantially EquivalentDiasorin S.P.Aaccessdata.fda.gov
April 29, 2005K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSLLMSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
May 7, 2026P250039LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM PlusMYM1June 24, 2026accessdata.fda.gov
March 29, 2024P220034LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG PlusMYL10August 18, 2026accessdata.fda.gov
August 29, 2020P190017LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory TestLOM25October 10, 2025accessdata.fda.gov
August 29, 2020P180049LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBeSEI19October 10, 2025accessdata.fda.gov
August 29, 2020P180048LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAgLOM19October 10, 2025accessdata.fda.gov
August 29, 2020P180045LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgMSEI19October 10, 2025accessdata.fda.gov
February 21, 2020P180039LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs VerifiersSEI21October 10, 2025accessdata.fda.gov
January 2, 2020P180038LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBcSEI26October 10, 2025accessdata.fda.gov
November 26, 2019P180047LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON SoftwareNCD42September 24, 2026accessdata.fda.gov
October 18, 2019P190011LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV AbMZO3August 10, 2021accessdata.fda.gov
March 30, 2001P990041DIASORIN ETI-AB-EBK PLUS ASSAY28December 21, 2021accessdata.fda.gov
February 8, 2001P990043DIASORIN ETI-EBK PLUS ASSAYLOM28December 21, 2021accessdata.fda.gov
August 6, 1999P970055BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)MYM21January 6, 2025accessdata.fda.gov
August 6, 1999P970054BIOTRIN PARVOVIRUS B19 IGGMYL18January 6, 2025accessdata.fda.gov

Compare with other makers

Updated June 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.