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U.S. FDA Medical Device Leukocyte Peroxidase Test Requirements


FDA Medical Device Definition: A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.

Registrar Corp assists Leukocyte Peroxidase Test companies with:

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