Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Chromosome Culture Kit Regulations

U.S. FDA Medical Device Chromosome Culture Kit Requirements


FDA Medical Device Definition: A chromosome culture kit is a device containing the necessary ingredients (e.g., Minimum Essential Media (MEM) of McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin) used to culture tissues for diagnosis of congenital chromosome abnormalities.

Registrar Corp assists Chromosome Culture Kit companies with:

  • FDA Chromosome Culture Kit Establishment Registration
  • FDA Chromosome Culture Kit Listing
  • FDA Chromosome Culture Kit Label Requirements and Exceptions
  • FDA Chromosome Culture Kit Import Information
  • FDA Chromosome Culture Kit Detentions (Chromosome Culture Kit Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Chromosome Culture Kit Manufacturers (Chromosome Culture Kit Suppliers)
       - Chromosome Culture Kit Distributors
       - Chromosome Culture Kit Processors
       - Chromosome Culture Kit Repackers
       - Chromosome Culture Kit Relabelers
       - Chromosome Culture Kit Exporters
       - Chromosome Culture Kit Importers
For more information about Chromosome Culture Kit 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco