TEST FOR HUMAN ALPHA ONE ACID GLYCO-
Device Facts
| Record ID | K831960 |
|---|---|
| Device Name | TEST FOR HUMAN ALPHA ONE ACID GLYCO- |
| Applicant | Kent Laboratories, Inc. |
| Product Code | LKL · Immunology |
| Decision Date | Jul 19, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5420 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.
