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U.S. FDA Medical Device Alkaline Phosphatase Requirements

FDA Medical Device Definition: A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic granulocytes (granular leukocytes stainable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate chronic granulocytic leukemia (a malignant disease characterized by excessive overgrowth of granulocytes in the bone marrow) and reactions that resemble true leukemia, such as those occuring in severe infections and polycythemia (increased total red cell mass).

Registrar Corp assists Alkaline Phosphatase companies with:

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