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

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