In vitro diagnostic company Hycor Biomedical disclosed on Wednesday that it has passed the US Food and Drug Administration's (FDA) 510(k) clearance for its new allergy testing system, NOVEOS.
NOVEOS, which employs microparticles, chemiluminescence and liquid ready-to-use reagent, provides the first-of-its-kind technology for routine allergy testing labs in over 20 years, added the company.
According to the company, NOVEOS addresses the common issues the laboratorians face with current technologies and now offers a significant reduction in sample size, reduced blood-based interferences, less variability within allergen lots, increased accuracy as well as improved walk-away time for laboratory technicians.
Additionally, the company received simultaneous clearance for the NOVEOS' first Specific IgE (sIgE) assay to detect Dust Mite allergen (D001) and is focused on the development of additional assays to provide a comprehensive menu to customers. NOVEOS product line recently received CE mark in the EU.
Inimmune signs research collaboration with Boston Children's Hospital
ResVita Bio receives USD250,000 phase one Small Business Innovation Research grant from NIAID
Phase II Data of Oral Dexpramipexole Published in Eosinophilic Asthma
AllerVie Health Rebrands Southern Allergy & Asthma
Applied BioCode Inks Distribution Agreement with Medline Industries
Vedanta Biosciences Receives Fast Track Designation for VE303
KalVista Pharmaceuticals Presents Data at 13th C1-inhibitor Deficiency & Angioedema Workshop
French Ophthalmology Specialist Horus Pharma Group Launches a Nordic Subsidiary