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U.S. FDA Medical Device Manual Colony Counter Requirements


FDA Medical Device Definition: A manual colony counter is a device intended for medical purposes that consists of a printed grid system superimposed on an illuminated screen. Petri plates containing bacterial colonies to be counted are placed on the screen for better viewing and ease of counting. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.

Registrar Corp assists Manual Colony Counter companies with:

  • FDA Manual Colony Counter Establishment Registration
  • FDA Manual Colony Counter Listing
  • FDA Manual Colony Counter Label Requirements and Exceptions
  • FDA Manual Colony Counter Import Information
  • FDA Manual Colony Counter Detentions (Manual Colony Counter Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Manual Colony Counter Manufacturers (Manual Colony Counter Suppliers)
       - Manual Colony Counter Distributors
       - Manual Colony Counter Processors
       - Manual Colony Counter Repackers
       - Manual Colony Counter Relabelers
       - Manual Colony Counter Exporters
       - Manual Colony Counter Importers
For more information about Manual Colony Counter Medical Devices, simply click below:






 
U.S. FDA Regulations:

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


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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