Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Automated Colony Counter Regulations

U.S. FDA Medical Device Automated Colony Counter Requirements


FDA Medical Device Definition: An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.

Registrar Corp assists Automated Colony Counter companies with:

  • FDA Automated Colony Counter Establishment Registration
  • FDA Automated Colony Counter Listing
  • FDA Automated Colony Counter Label Requirements and Exceptions
  • FDA Automated Colony Counter Import Information
  • FDA Automated Colony Counter Detentions (Automated Colony Counter Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Automated Colony Counter Manufacturers (Automated Colony Counter Suppliers)
       - Automated Colony Counter Distributors
       - Automated Colony Counter Processors
       - Automated Colony Counter Repackers
       - Automated Colony Counter Relabelers
       - Automated Colony Counter Exporters
       - Automated Colony Counter Importers
For more information about Automated 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco