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U.S. FDA Medical Device Micro Pipette 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 Micro Pipette companies with:

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