Medical Device Manufacturer · US , Ellicott City , MD

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

71 submissions · 70 cleared · Since 1998

Recent clearances: LIAISON Murex HBsAg Qual, LIAISON VZV IgG HT, LIAISON Control VZV IgG HT, LIAISON Anti-HAV

Total

Cleared

Denied

DiaSorin, Inc. has 70 FDA 510(k) cleared medical devices. Based in Ellicott City, US.

Latest FDA clearance: Jun 2026. 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.

Regulatory submissions have been managed by Tuv Product Service, Inc. and Tuv America, Inc.. 2 devices have linked clinical trials registered on ClinicalTrials.gov.

DiaSorin, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - DiaSorin, Inc.

71 devices

1-12 of 71

Cleared Jun 04, 2026

LIAISON Murex HBsAg Qual

K260770 · LOM

Microbiology · 87d

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

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Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Jun 08, 2026

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

FDA 510(k) Regulatory Record - DiaSorin, Inc.

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