FDA 510(k), STRATIFY JCV DXSELECT, FOCUS DIAGNOSTICS, INC.
FDA 510(k), STRATIFY JCV DXSELECT, FOCUS DIAGNOSTICS, INC.
Device Name: STRATIFY JCV DXSELECT
Manufacturer: FOCUS DIAGNOSTICS, INC.
Device Classification Name: Anti-Jcv Antibody Detection Assay
Regulation Number: 866.3336
Classification Product Code: OYP
Date Received: 04/02/2012
Decision Date: 08/16/2012
Regulation Medical Specialty: Microbiology
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