DET · Lactic Dehydrogenase, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5560 · Class 1
Overview
| Product Code | DET |
|---|---|
| Device Name | Lactic Dehydrogenase, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5560 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900107 | LD-1 | Boehringer Mannheim Corp. | Jan 18, 1990 | SESE |
Top Applicants
- Boehringer Mannheim Corp. — 1 clearance
