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U.S. FDA Medical Device Legionella DNA-Reagents 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 Legionella DNA-Reagents companies with:

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