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U.S. FDA Medical Device Beta-Glucan Serological Assays Requirements: Beta-Glucan Serological Assays

FDA Medical Device Definition: Beta-glucan serological assays are devices that consist of antigens or proteases used in serological assays. The device is intended for use for the presumptive diagnosis of fungal infection. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias

Registrar Corp assists Beta-Glucan Serological Assays companies with:

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