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U.S. FDA Medical Device Leukocyte Typing 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 Typing Test companies with:

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