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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / DEN250032

510(k) cleared

LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)

DiaSorin, Inc. · Dec 23, 2025 · DEN250032

FDA cleared the LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) from DiaSorin, Inc. on Dec 23, 2025 under DEN250032, a direct 510(k). The device falls under product code SGW, Device To Detect Antibodies To Hepatitis D Virus, regulated at 21 CFR 866.3176 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Jul 30, 2025. The decision came 146 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

DiaSorin, Inc. has 2 other decisions in the tracker over the last 12 months: K260770 (LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX), P250039 (LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus).

Questions & Answers

What did FDA clear under DEN250032?

DEN250032 is the FDA 510(k) for LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261), submitted by DiaSorin, Inc.. FDA's decision date was Dec 23, 2025, under product code SGW (Device To Detect Antibodies To Hepatitis D Virus).

Who makes the LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)?

DiaSorin, Inc., based in Stillwater, MN, is the applicant of record for DEN250032.

How long did the DEN250032 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Dec 23, 2025, 146 days later.

← All decisions in December 2025

Sources