BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DIASORIN INC.

    Reg #: 2182595 · FEI: 2182595 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    127
    Establishment Types
    6
    Classifications
    46

    Registration Details

    Registration Name
    DIASORIN INC.
    Registration Number
    2182595
    FEI Number
    2182595
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1951 Northwestern Ave
    City
    Stillwater
    State
    MN
    ZIP
    55082
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193532

    Owner / Operator

    Firm Name
    DiaSorin Inc.
    Operator Number
    9051149
    Address
    1951 Northwestern Ave
    City
    Stillwater
    State
    MN
    Postal Code
    55082
    Country
    US
    Correspondent
    Mari Meyer

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hepatitis A Test (Antibody And Igm Antibody) LOL
    Analyzer, Chemistry, Micro, For Clinical Use JJF
    Enzyme Linked Immunoabsorbent Assay, Rotavirus LIQ
    Radioimmunoassay, Calcitonin JKR
    Radioimmunoassay, Progesterone JLS
    Calprotectin, Fecal NXO
    Electrophoretic Separation, Alkaline Phosphatase Isoenzymes CIN
    Assayed Quality Control Material For Clinical Microbiology Assays QCH
    Reagent, Borrelia Serological Reagent LSR
    Calibrator, Secondary JIT
    Transferrin, Antigen, Antiserum, Control DDG
    System, Test, Vitamin D MRG
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 MYF
    Zika Virus Serological Reagents QFO
    Reagents, Specific, Analyte MVU
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    System, Test, Osteocalcin NEO
    Research Use Only/Immunology Devices OTR
    Apolipoproteins MSJ
    Antigen, C. Difficile MCB
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Research Use Only/Clinical Chemistry Devices OTV
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 MXJ
    Campylobacter Spp. LQP
    Radioimmunoassay, Parathyroid Hormone CEW
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Complement C9, Antigen, Antiserum, Control DAE
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis NCD
    Helicobacter Pylori LYR
    Acid, Folic, Radioimmunoassay CGN
    Calibrator, Multi-Analyte Mixture JIX
    Albumin, Antigen, Antiserum, Control DCF
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP
    Immunoassay For Host Biomarkers Of Infection QPS
    Radioimmunoassay, Androstenedione CIZ
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Reagent, Coronavirus Serological QKO
    P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin JNN
    Antigens, All Types, Escherichia Coli GMZ
    Radioassay, Vitamin B12 CDD
    Radioimmunoassay, Estradiol CHP
    Radioimmunoassay, Aldosterone CJM

    Proprietary Names

    LIAISON XL 1,25 Dihydroxyvitamin D Controls LIAISON® MeMed BV® Calibration Verifiers LIAISON XS Analyzer LIAISON Disposable Tips (x0055) LIAISON EASY Starter kit (319300) LIAISON EASY Wash Buffer (319301) LIAISON Anti-HAV LIAISON Cuvettes on tray (X0053) LIAISON EASY System Liquid LIAISON EASY Cleaning Tool (310996) LIAISON® diluteX LIAISON Light Check LIAISON Wash/System Liquid LIAISON XL Clean Tool LIAISON Light Check 12 LIAISON Starter kit LIAISON Clean Kit LIAISON XL Starter kit LIAISON Analyzer LIAISON XL Analyzer LIAISON ROTAVIRUS LIAISON ROTAVIRUS Control set LIAISON Calcitonin II Gen LIAISON Calcitonin II Gen Control Set LIAISON Progesterone II Gen Control Set LIAISON Progesterone II Gen LIAISON Q.S.E.T. Buffer LIAISON Calprotectin LIAISON Q.S.E.T. Device LIAISON Calprotectin Control Set LIAISON Calprotectin Calibration Verifiers LIAISON Q.S.E.T. Device Plus LIAISON BAP OSTASE LIAISON BAP OSTASE Control Set LIAISON Lyme IgM Control LIAISON Lyme Total Antibody Plus LIAISON Lyme IgM LIAISON XL 1,25 Dihydroxyvitamin D LIAISON XL 1,25 Dihydroxyvitamin D Calibration Verifiers LIAISON HSV-2 Type Specific IgG LIAISON Control HSV-2 IgG LIAISON® EBV IgM Serum Control Set LIAISON(R) Borrelia burgdorferi Ser LIAISON(R) Borrelia burgdorferi LIAISON XL Zika Capture IgM II Control Set LIAISON XL Zika Capture IgM II LIAISON® Adenovirus Control Set LIAISON® Adenovirus LIAISON Osteocalcin LIAISON Osteocalcin control set LIAISON Q.S.E.T Device S100B ELISA TK-REA LIAISON NSE LIAISON TK LIAISON C. DIFFICILE GDH CONTROL SET LIAISON C. DIFFICILE GDH LIAISON C. Difficile Toxins A&B Control Set LIAISON C. Difficile Toxins A&B nDNA Fluoro-Kit 100 (Crithidia luci nDNA Fluoro-Kit 50 (Crithidia lucil LIAISON Lyme IgG Control set LIAISON Lyme IgG LIAISON IQ Reader LIAISON 1-84 AldoCTK - RIA LIAISON HSV-1 Type Specific IgG LIAISON Control HSV-1 IgG LIAISON Lyme Total Antibody Plus Control Set LIAISON 25 OHD TOTAL Cal Verifiers LIAISON Campylobacter Ag Control Set LIAISON Campylobacter Ag LIAISON 1-84 PTH Control Set LIAISON 1-84 PTH Assay LIAISON 1-84 PTH Cal Verifiers LIAISON 1-84 PTH Specimen Diluent LIAISON SHBG LIAISON SHBG Control Set COMPLEMENT ACTIVATION EIA (CAE) KIT LIAISON Endocrinology Calibration Verifiers LIAISON® Control QuantiFERON®-TB Gold Plus II LIAISON® QuantiFERON®-TB Gold Plus LIAISON® QuantiFERON® Software LIAISON® Control QuantiFERON®-TB Gold Plus LIAISON® QuantiFERON®-TB Gold Plus II LIAISON H. pylori IgG LIAISON H. pylori IgG Control Set LIAISON Folate Control Set LIAISON Folate Calibration Verifiers LIAISON Folate LIAISON(R) Treponema Assay LIAISON(R)Treponema Control Set LIAISON® MeMed BV® Assay LIAISON 25 OH Vitamin D TOTAL Cntrl LIAISON 25 OH Vitamin D TOTAL Assay LIAISON 25 OH Vitamin D TOTAL Specimen Diluent LIAISON® N-TACT® PTH Gen II Specimen Diluent LIAISON® N-TACT® PTH Gen II Control Set LIAISON® N-TACT® PTH Gen II Calibration Verifiers LIAISON® N-TACT® PTH Gen II LIAISON Androstenedione Control Set LIAISON Androstenedione LIAISON Calprotectin Stool Extraction Device LIAISON Reaction Modules (319130) LIAISON XL Cuvettes (X0016) LIAISON Cuvettes on Tray (X0053) LIAISON XL Disposable Tips (X0015 and X0055) LIAISON® Quick Detect COVID TrimericS Ab Control Set LIAISON® Quick Detect COVID TrimericS Ab LIAISON Elastase-1 LIAISON Elastase-1 Control Set LIAISON Elastase-1 Calibration Verifiers LIAISON Meridian H. pylori SA Control Set LIAISON Meridian H. pylori SA LIAISON® Testosterone LIAISON® Testosterone Control Set LIAISON EHEC LIAISON Vitamin B12 Calibration Verifiers LIAISON Vitamin B12 Control Set LIAISON 25 OH Vitamin D TOTAL Assay (200 test) LIAISON® Estradiol II Gen LIAISON® Estradiol II Gen Control Set LIAISON Aldosterone Calibration Verifiers LIAISON Aldosterone Control Set LIAISON Aldosterone LIAISON® SARS-CoV-2 TrimericS IgG Control Set LIAISON® SARS-CoV-2 TrimericS IgG

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198