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U.S. FDA Medical Device Hepatitis A Virus Serological Assays Requirements: Hepatitis A Virus Serological Assays

FDA Medical Device Definition: HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors

Registrar Corp assists Hepatitis A Virus Serological Assays companies with:

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