Medical Device Manufacturer · US , Ellicott City , MD

DiaSorin, Inc. - FDA 510(k) Cleared Devices

70 submissions · 69 cleared · Since 1998

Total

Cleared

Denied

DiaSorin, Inc. has 69 FDA 510(k) cleared medical devices. Based in Ellicott City, US.

Last cleared in 2023. Active since 1998. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by DiaSorin, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by DiaSorin, Inc.

70 devices

1-12 of 70

Not Cleared Dec 23, 2025

LIAISON® XL MUREX Anti-HDV (318260)

DEN250032 · SGW

Microbiology · 146d

Cleared Oct 27, 2023

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus

K213858 · NXO

Immunology · 228d

Cleared Jul 14, 2022

LIAISON MeMed BV, LIAISON MeMed BV Control Set

LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus

K202573 · LSR

Microbiology · 167d

Cleared Feb 18, 2021

LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus

LIAISON Testosterone xt

LIAISON Anti-HAV Assay

K193532 · LOL

Microbiology · 73d

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DiaSorin, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by DiaSorin, Inc.

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