Diasorin Molecular, LLC

Diasorin Molecular, LLC — FDA 510(k) Submissions

Diasorin Molecular, LLC has submitted 13 FDA 510(k) premarket notifications since 2018, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents, Bordetella Pertussis Dna Assay System, Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples, Device To Detect Microbial Colonization Directly From Clinical Specimens., Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test . Use the specialty filter in the sidebar to narrow results.