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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 / May 2026 / P250039

PMA approved

LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus

DiaSorin, Inc. · May 7, 2026 · P250039

FDA approved the LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus from DiaSorin, Inc. on May 7, 2026 under P250039, an original premarket approval. The device falls under product code MYM, Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm as a Class 3 device. The review panel was Microbiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 220 days later.

DiaSorin, Inc. has 2 other decisions in the tracker over the last 12 months: K260770 (LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX), DEN250032 (LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)).

Questions & Answers

What did FDA approve under P250039?

P250039 is the FDA PMA for LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus, submitted by DiaSorin, Inc.. FDA's decision date was May 7, 2026, under product code MYM (Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm).

Who makes the LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus?

DiaSorin, Inc., based in Stillwater, MN, is the applicant of record for P250039.

How long did the P250039 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on May 7, 2026, 220 days later.

← All decisions in May 2026

Sources