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U.S. FDA Medical Device Mycoplasma Spp. DNA-Reagents Requirements


FDA Medical Device Definition: Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toMycoplasma spp. in serum. Additionally, some of these reagents consist ofMycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyMycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusMycoplasma and provides epidemiological information on diseases caused by these microorganisms.Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection withMycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.

Registrar Corp assists Mycoplasma Spp. DNA-Reagents companies with:

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