GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
Device Facts
| Record ID | K933934 |
|---|---|
| Device Name | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | JBF · Hematology |
| Decision Date | Jun 29, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7360 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.
