ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
Device Facts
| Record ID | K896092 |
|---|---|
| Device Name | ALKALINE PHOSPHATASE, LEUKOCYTE, KIT |
| Applicant | Sigma Chemical Co. |
| Product Code | GHD · Hematology |
| Decision Date | Nov 9, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7660 |
| Device Class | Class 1 |
Regulatory Classification
Identification
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).
