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U.S. FDA Medical Device Blood Tube Mixer Requirements

FDA Medical Device Definition: General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

Registrar Corp assists Blood Tube Mixer companies with:

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