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Home » FDA Outlines Criteria on 510(k)s for Nucleic Acid Assays
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FDA Outlines Criteria on 510(k)s for Nucleic Acid Assays
January 16, 2009
Makers of enterovirus nucleic acid assays should demonstrate that the assay can detect all 64 serotypes associated with aseptic meningitis, according to a new FDA guidance.