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U.S. FDA Medical Device CFTR Gene Mutation Detection Requirements: CFTR Gene Mutation Detection

FDA Medical Device Definition: The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation, or population screening

Registrar Corp assists CFTR Gene Mutation Detection companies with:

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