MYOGLOBIN ELISA TEST KIT
Device Facts
| Record ID | K923195 |
|---|---|
| Device Name | MYOGLOBIN ELISA TEST KIT |
| Applicant | Immuno Diagnostic Center, Inc. |
| Product Code | DDR · Immunology |
| Decision Date | Nov 6, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5680 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
