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U.S. FDA Medical Device Cryptosporidium Spp. Requirements

FDA Medical Device Definition: Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.

Registrar Corp assists Cryptosporidium Spp. companies with:

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