Medical Device Manufacturer · US , Ellicott City , MD

DiaSorin, Inc.

70 submissions · 69 cleared · Since 1998
70
Total
69
Cleared
1
Denied

DiaSorin, Inc. — FDA 510(k) Submissions

DiaSorin, Inc. has submitted 70 FDA 510(k) premarket notifications since 1998, of which 69 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hepatitis A Test (antibody And Igm Antibody), System, Test, Vitamin D, Epstein-barr Virus, Other, Reagent, Borrelia Serological Reagent, Single (specified) Analyte Controls (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

70 devices
1–25 of 70
LIAISON? XL MUREX Anti-HDV (318260); LIAISON? XL MUREX Control Anti-HDV (318261)
DEN250032 · SGW Device To Detect... · Microbiology
Dec 2025 146d
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214 · LFY Enzyme Linked... · Microbiology
Oct 2023 182d
LIAISON Anti-HAV; LIAISON XS
K223403 · LOL Hepatitis A Test... · Microbiology
Dec 2022 30d
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
K213858 · NXO Calprotectin, Fecal · Immunology
Jul 2022 228d
LIAISON MeMed BV, LIAISON MeMed BV Control Set
K213936 · QPS Immunoassay For Host... · Microbiology
Jul 2022 210d
LIAISON Ferritin
K193650 · DBF Ferritin, Antigen,... · Immunology
Sep 2021 624d
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
K202573 · LSR Reagent, Borrelia... · Microbiology
Feb 2021 167d
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
K202574 · LSR Reagent, Borrelia... · Microbiology
Feb 2021 167d
LIAISON Anti-HAV
K210272 · LOL Hepatitis A Test... · Microbiology
Feb 2021 8d
LIAISON Testosterone xt
K201908 · CDZ Radioimmunoassay,... · Chemistry
Oct 2020 98d
LIAISON? Folate
K192586 · CGN Acid, Folic,... · Chemistry
May 2020 230d
LIAISON Anti-HAV Assay
K193532 · LOL Hepatitis A Test... · Microbiology
Mar 2020 73d
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
K193051 · LSR Reagent, Borrelia... · Microbiology
Jan 2020 89d
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
K192046 · QFO Zika Virus Serological... · Microbiology
Oct 2019 89d
LIAISON Vitamin B12
K192064 · CDD Radioassay, Vitamin B12 · Chemistry
Oct 2019 62d
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
K182698 · NXO Calprotectin, Fecal · Immunology
Dec 2018 90d
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · LYR Helicobacter Pylori · Microbiology
Aug 2018 88d
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
K173683 · PRI Procalcitonin Assay · Microbiology
Feb 2018 88d
LIAISON? CMV IgG and LIAISON? CMV IgG Serum Control Set
K162969 · LFZ Enzyme Linked... · Microbiology
Jan 2017 74d
LIAISON? VCA IgG and LIAISON? VCA IgG Serum Control Set; LIAISON? EBNA IgG and LIAISON? EBNA IgG Serum Control Set
K162961 · LSE Epstein-barr Virus, Other · Microbiology
Jan 2017 73d
LIAISON? EA IgG and LIAISON? EA IgG Serum Control Set
K162959 · LSE Epstein-barr Virus, Other · Microbiology
Jan 2017 72d
LIAISON HAV IgM, LIAISON Control HAV IgM
K160650 · LOL Hepatitis A Test... · Microbiology
Aug 2016 170d
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
K161139 · LYR Helicobacter Pylori · Microbiology
Jul 2016 91d
LIAISON EBV IgM Serum Control Set
K161522 · JJX Single (specified)... · Microbiology
Jun 2016 28d
LIAISON CMV IgM Serum Control Set
K161526 · JJX Single (specified)... · Microbiology
Jun 2016 28d
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