510(k) Report

FDA applicant

DiaSorin, Inc.

Stillwater, MN97 decisions1990–202616 recalls

FDA records 97 decisions for DiaSorin, Inc. (Stillwater, MN) from 1990 to 2026: 73 510(k) clearances, 1 De Novo grant and 23 original PMA approvals. Most are in product codes LOL (Hepatitis A Test (Antibody And Igm Antibody)) and LOM (Test, Hepatitis B (B Antigen, B Surface…). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 82 predicates, 40 of them its own earlier devices. 16 recalls are linked to its devices.

FDA’s records also spell it “Diasorin”, “Diasorin S.P.A”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided DiaSorin, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 32008: 52009: 22011: 12012: 22013: 102014: 22015: 22016: 42017: 32018: 32019: 42020: 102021: 42022: 32023: 12024: 12025: 12026 (partial year): 2
2007high 10 (2013) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2024

2008: 22010: 12015: 12020: 22023: 12024: 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — DiaSorin, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like DiaSorin, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LOLHepatitis A Test (Antibody And Igm Antibody)10decisions
  • LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)6decisions
  • MRGSystem, Test, Vitamin D6decisions
  • LSEEpstein-Barr Virus, Other5decisions
  • SEIQualitative And Quantitative Hepatitis B Virus Antibody Assays4decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)4decisions

Also: LSR (4), LFX (3), LGD (3), LFY (3), CEW (3), DFC (3).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 89 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 3 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 82 predicates; 40 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 61 times; 40 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc. · 20126cite it
  • K071480Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602DiaSorin, Inc. · 20076cite it
  • K040120Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysDiaSorin, Inc. · 20054cite it
  • K061247Diasorin Liaison Treponema AssayDiaSorin, Inc. · 20063cite it
  • K033426Liaison N-Tact PTHDiaSorin, Inc. · 20043cite it
  • K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 20053cite it

What has FDA decided for it lately?

  • K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. · 2026
  • P250039LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM PlusDiaSorin, Inc. · 2026
  • DEN250032LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)DiaSorin, Inc. · 2025
  • P220034LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG PlusDiaSorin, Inc. · 2024
  • K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTDiaSorin, Inc. · 2023
  • K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc. · 2022
  • K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 20221 recall
  • K213936LIAISON MeMed BV, LIAISON MeMed BV Control SetDiaSorin, Inc. · 2022

All 90 as DiaSorin, Inc. →All 5 as Diasorin →All 2 as Diasorin S.P.A →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K213858DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation…Nov 7, 2024Class II
  • K081687DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620Dec 13, 2023Class II
  • K150879LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay…Nov 23, 2020Class II
  • P970054Parvovirus B19 IgG EIA kit Part No. V519IGUSJul 17, 2020Class II
  • P970025DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The…Mar 16, 2015Class II
  • P990042ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy…Aug 19, 2010

Other applicant names beginning “DiaSorin”

FDA records each applicant name separately; these may or may not be the same firm.

Diasorin Molecular, LLC 14Diasorin/American Standard Companies 1