Company · US
DiaSorin, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
74510(k) clearances (2 in 12 months)
39recalls (0 in 12 months)
29recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MRG | System, Test, Vitamin D | 11 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 9 |
| LSE | Epstein-Barr Virus, Other | 6 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 4 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 4 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 4 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 3 |
| NXO | Calprotectin, Fecal | 3 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 2 |
| CIZ | Radioimmunoassay, Androstenedione | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| LCI | Automated Radioimmunoassay Systems, For Clinical Use | 2 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 4, 2026 | K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX DiaSorin, Inc. | LOM |
| Dec 23, 2025 | DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) DiaSorin, Inc. | SGW |
| Oct 27, 2023 | K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT DiaSorin, Inc. | LFY |
| Dec 9, 2022 | K223403 | LIAISON Anti-HAV; LIAISON XS DiaSorin, Inc. | LOL |
| Jul 26, 2022 | K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus DiaSorin, Inc. | NXO |
| Jul 14, 2022 | K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set DiaSorin, Inc. | QPS |
| Sep 14, 2021 | K193650 | LIAISON Ferritin DiaSorin, Inc. | DBF |
| Feb 18, 2021 | K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus DiaSorin, Inc. | LSR |
| Feb 18, 2021 | K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus DiaSorin, Inc. | LSR |
| Feb 9, 2021 | K210272 | LIAISON Anti-HAV DiaSorin, Inc. | LOL |
| Oct 15, 2020 | K201908 | LIAISON Testosterone xt DiaSorin, Inc. | CDZ |
| May 6, 2020 | K192586 | LIAISON® Folate DiaSorin, Inc. | CGN |
| Mar 2, 2020 | K193532 | LIAISON Anti-HAV Assay DiaSorin, Inc. | LOL |
| Jan 29, 2020 | K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set DiaSorin, Inc. | LSR |
| Oct 28, 2019 | K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set DiaSorin, Inc. | QFO |
| Oct 2, 2019 | K192064 | LIAISON Vitamin B12 DiaSorin, Inc. | CDD |
| Dec 26, 2018 | K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buf DiaSorin, Inc. | NXO |
| Aug 31, 2018 | K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set DiaSorin, Inc. | LYR |
| Feb 27, 2018 | K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers DiaSorin, Inc. | PRI |
| Jan 6, 2017 | K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set DiaSorin, Inc. | LFZ |
| Jan 5, 2017 | K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set DiaSorin, Inc. | LSE |
| Jan 4, 2017 | K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set DiaSorin, Inc. | LSE |
| Aug 25, 2016 | K160650 | LIAISON HAV IgM, LIAISON Control HAV IgM DiaSorin, Inc. | LOL |
| Jul 22, 2016 | K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set DiaSorin, Inc. | LYR |
| Jun 30, 2016 | K161526 | LIAISON CMV IgM Serum Control Set DiaSorin, Inc. | JJX |
| Jun 30, 2016 | K161522 | LIAISON EBV IgM Serum Control Set DiaSorin, Inc. | JJX |
| Jun 22, 2015 | K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers DiaSorin, Inc. | CEW |
| Mar 11, 2015 | K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG DiaSorin, Inc. | LFY |
| Dec 10, 2014 | K141463 | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS DiaSorin, Inc. | MRG |
| Jul 25, 2014 | K141116 | LIAISON XL ANALYZER DiaSorin, Inc. | LOL |
| Nov 8, 2013 | K132515 | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DiaSorin, Inc. | CEW |
| Sep 6, 2013 | K131037 | LIAISON XL HCG DiaSorin, Inc. | DHA |
| Sep 5, 2013 | K132492 | LIAISON 25 TOTAL-D DiaSorin, Inc. | MRG |
| Aug 28, 2013 | K132234 | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II DiaSorin, Inc. | LGD |
| Aug 9, 2013 | K131441 | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II DiaSorin, Inc. | LGD |
| Apr 9, 2013 | K130321 | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS Diasorin | CJM |
| Apr 5, 2013 | K130469 | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 DiaSorin, Inc. | JLW |
| Apr 4, 2013 | K121951 | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 DiaSorin, Inc. | CEC |
| Jan 25, 2013 | K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET DiaSorin, Inc. | CDZ |
| Jan 1, 2013 | K121944 | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT DiaSorin, Inc. | CIB |
| Sep 6, 2012 | K122397 | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM DiaSorin, Inc. | LFX |
| Jan 20, 2012 | K112725 | LIAISON 25 OH VITAMIN D TOTAL ASSAY DiaSorin, Inc. | MRG |
| Jan 21, 2011 | K103529 | LIAISON XL ANALYZER MODEL 10050 DiaSorin, Inc. | LOL |
| Dec 14, 2009 | K093498 | LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 DiaSorin, Inc. | JJX |
| Sep 9, 2009 | K090104 | LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 DiaSorin, Inc. | JJX |
| Dec 5, 2008 | K082049 | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV DiaSorin, Inc. | LOL |
| Nov 21, 2008 | K073390 | DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS DiaSorin, Inc. | LFX |
| Nov 18, 2008 | K081685 | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG DiaSorin, Inc. | MXJ |
| Nov 10, 2008 | K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG DiaSorin, Inc. | MYF |
| Nov 3, 2008 | K082050 | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM DiaSorin, Inc. | LOL |
Newest 50 of 74.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2024 | Diasorin Inc. DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens Open, Classified |
NXO | K213858 |
| Jan 25, 2024 | Diasorin Inc. DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 Open, Classified |
MYF | K081687 |
| Nov 23, 2020 | Diasorin Inc. LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Mea Terminated |
CEW | K150879 |
| Jul 17, 2020 | Diasorin Inc. Parvovirus B19 IgG EIA kit
Part No. V519IGUS Open, Classified |
MYL | None listed |
| Jul 13, 2016 | Diasorin Inc. LIAISON Estradiol II Gen, 310680, 310680-CN
The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human seru Terminated |
CHP | None listed |
| Apr 20, 2015 | Diasorin Inc. DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN.
Product Usage:
The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tac Terminated |
MLM | None listed |
| Mar 22, 2011 | Diasorin Inc. ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285
In vitro enzyme immunoa Terminated |
LOM | None listed |
| Jun 28, 2010 | Diasorin Inc. GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285.
Indicated for the quantitative determination of plasm Terminated |
CIB | None listed |
| Mar 2, 2010 | Diasorin Inc. DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28. Terminated |
LFX | K960367 |
| Mar 30, 2009 | Diasorin Inc. Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970.
Colorimeter, Photometer, Spectrophotometer for clinical use. Terminated |
JJQ | K032844 |
| May 7, 2008 | Diasorin Inc. LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082 Terminated |
MRG | K032844 |
| Sep 20, 2007 | Diasorin Inc. 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Terminated |
MRG | K953567 |
| Apr 24, 2007 | Diasorin Inc. DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic.
For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Terminated |
LLM | K946158 |
| Apr 14, 2007 | Diasorin Inc. DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples) Terminated |
JNO | K791202 |
| Apr 3, 2007 | Diasorin Inc. 1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA Terminated |
MRG | K014030 |
| Feb 23, 2006 | Diasorin Inc. The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1). Terminated |
LJY | K991274 |
| Oct 1, 2005 | Diasorin Inc. ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. Terminated |
MZO | None listed |
| Jun 25, 2005 | Diasorin Inc. DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom. Terminated |
MID | K001981 |
| May 10, 2005 | Diasorin Inc. Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test. Terminated |
DHN | K822397 |
| Apr 28, 2005 | Diasorin Inc. Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Terminated |
LIP | K001552 |
| Apr 27, 2005 | Diasorin Inc. DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Terminated |
LOL | None listed |
| Apr 13, 2005 | Diasorin Inc. DiaSorin Analyte Specific Reagent Terminated |
DGK | None listed |
| Apr 13, 2005 | Diasorin Inc. DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-02 Terminated |
LCI | K983617 |
| Apr 13, 2005 | Diasorin Inc. DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-02 Terminated |
CIZ | K854650 |
| Apr 13, 2005 | Diasorin Inc. Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays. Terminated |
JTC | K884125 |
| Apr 13, 2005 | Diasorin Inc. Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit Terminated |
MLM | None listed |
| Apr 6, 2005 | Diasorin Inc. PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Tes Terminated |
DHN | K822397 |
| Apr 6, 2005 | Diasorin Inc. Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700) Terminated |
JZO | K952183 |
| Apr 6, 2005 | Diasorin Inc. Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Terminated |
MSV | K982879 |
| Apr 6, 2005 | Diasorin Inc. Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit Terminated |
DBM | K921183 |
| Apr 6, 2005 | Diasorin Inc. Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay. Terminated |
LLL | K944505 |
| Mar 29, 2005 | Diasorin Inc. DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C Terminated |
LSE | K992191 |
| Mar 18, 2005 | Diasorin Inc. Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 Terminated |
MRG | K032844 |
| Mar 18, 2005 | Diasorin Inc. LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E. Terminated |
MRG | K032844 |
| Mar 18, 2005 | Diasorin Inc. Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent K Terminated |
DFC | K982708 |
| Mar 18, 2005 | Diasorin Inc. DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative determination of androstenedione levels i Terminated |
CIZ | K854650 |
| Mar 18, 2005 | Diasorin Inc. ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 47 Terminated |
LAZ | None listed |
| Mar 18, 2005 | Diasorin Inc. DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwester Terminated |
MID | K001981 |
| Mar 8, 2005 | Diasorin Inc. Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285 Terminated |
LFY | K900688 |