REAGENT SYSTEM
Device Facts
| Record ID | K760821 |
|---|---|
| Device Name | REAGENT SYSTEM |
| Applicant | Sigma Chemical Co. |
| Product Code | CJT · Clinical Chemistry |
| Decision Date | Oct 21, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1040 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.
