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U.S. FDA Medical Device Blastomyces Dermatitidis Eia Requirements


FDA Medical Device Definition: Blastomyces dermatitidis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toBlastomyces determatitidis in serum. The identification aids in the diagnosis of blastomycosis caused by the fungusBlastomyces dermatitidis. Blastomycosis is a chronic granulomatous (tumor-like) disease, which may be limited to the skin or lung or may be widely disseminated in the body resulting in lesions of the bones, liver, spleen, and kidneys.

Registrar Corp assists Blastomyces Dermatitidis Eia companies with:

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