LD-1
Device Facts
| Record ID | K900107 |
|---|---|
| Device Name | LD-1 |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | DET · Immunology |
| Decision Date | Jan 18, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5560 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels.
