SIGMA REAGENT SYSTEM NO. 885
Device Facts
| Record ID | K822733 |
|---|---|
| Device Name | SIGMA REAGENT SYSTEM NO. 885 |
| Applicant | Sigma Chemical Co. |
| Product Code | JBE · Hematology |
| Decision Date | Dec 3, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.
