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U.S. FDA Medical Device Pasteur Pipette Requirements

FDA Medical Device Definition: A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

Registrar Corp assists Pasteur Pipette companies with:

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