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U.S. FDA Medical Device Herpes Simplex Virus Serological Assays Requirements: Herpes Simplex Virus Serological Assays

FDA Medical Device Definition: Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome

Registrar Corp assists Herpes Simplex Virus Serological Assays companies with:

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


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