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U.S. FDA Medical Device Fluorescencein Situhybridization Enumeration Requirements: Fluorescencein Situhybridization Enumeration

FDA Medical Device Definition: An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens

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  • FDA Fluorescencein Situhybridization Enumeration Establishment Registration
  • FDA Fluorescencein Situhybridization Enumeration Listing
  • FDA Fluorescencein Situhybridization Enumeration Label Requirements and Exceptions
  • FDA Fluorescencein Situhybridization Enumeration Import Information
  • FDA Fluorescencein Situhybridization Enumeration Detentions (Fluorescencein Situhybridization Enumeration Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Fluorescencein Situhybridization Enumeration Manufacturers (Fluorescencein Situhybridization Enumeration Suppliers)
       - Fluorescencein Situhybridization Enumeration Distributors
       - Fluorescencein Situhybridization Enumeration Processors
       - Fluorescencein Situhybridization Enumeration Repackers
       - Fluorescencein Situhybridization Enumeration Relabelers
       - Fluorescencein Situhybridization Enumeration Exporters
       - Fluorescencein Situhybridization Enumeration Importers
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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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