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U.S. FDA Medical Device Automated Tissue Stainer Requirements


FDA Medical Device Definition: An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

Registrar Corp assists Automated Tissue Stainer companies with:

  • FDA Automated Tissue Stainer Establishment Registration
  • FDA Automated Tissue Stainer Listing
  • FDA Automated Tissue Stainer Label Requirements and Exceptions
  • FDA Automated Tissue Stainer Import Information
  • FDA Automated Tissue Stainer Detentions (Automated Tissue Stainer Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Automated Tissue Stainer Manufacturers (Automated Tissue Stainer Suppliers)
       - Automated Tissue Stainer Distributors
       - Automated Tissue Stainer Processors
       - Automated Tissue Stainer Repackers
       - Automated Tissue Stainer Relabelers
       - Automated Tissue Stainer Exporters
       - Automated Tissue Stainer Importers
For more information about Automated Tissue Stainer 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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