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).
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.
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