FDA Ends Roche s Aspirations for Marketing its AmpliChip CYP450 Microarray as an ASR | GenomeWeb

The Roche Molecular Diagnostics' microarray, the AmpliChip CYP450, may not enter the market without an agency premarket approval, the US Food and Drug Administration said this week.

The agency opted not to make a determination on whether or not the AmpliChip is an analyte specific reagent.

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