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U.S. FDA Medical Device Microtitrator Requirements

FDA Medical Device Definition: A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure "micro" volume of a known standardized solution.

Registrar Corp assists Microtitrator companies with:

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