Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Haemophilus Spp. DNA-Probe Regulations

U.S. FDA Medical Device Haemophilus Spp. DNA-Probe Requirements


FDA Medical Device Definition: Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identifyHaemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusHaemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused byHaemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).

Registrar Corp assists Haemophilus Spp. DNA-Probe companies with:

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