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U.S. FDA Medical Device Drug Metabolizing Enzyme Genotyping Requirements: Drug Metabolizing Enzyme Genotyping

FDA Medical Device Definition: A drug metabolizing enzyme genotyping is a device intended for use in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information

Registrar Corp assists Drug Metabolizing Enzyme Genotyping companies with:

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




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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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