DETER. OF PHOSPHOHEXOSE ISOMERASE
Device Facts
| Record ID | K770577 |
|---|---|
| Device Name | DETER. OF PHOSPHOHEXOSE ISOMERASE |
| Applicant | Sigma Chemical Co. |
| Product Code | KLJ · Clinical Chemistry |
| Decision Date | Jun 17, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1570 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A phosphohexose isomerase test system is a device intended to measure the activity of the enzyme phosphohexose isomerase in serum. Measurements of phosphohexose isomerase are used in the diagnosis and treatment of muscle diseases such as muscular dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic carcinoma.
