Cepheid

Cepheid — FDA 510(k) Submissions

Cepheid has submitted 60 FDA 510(k) premarket notifications since 2006, of which 57 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, Respiratory Virus Panel Nucleic Acid Assay System, Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents, Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System . Use the specialty filter in the sidebar to narrow results.