SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN
Device Facts
| Record ID | K760143 |
|---|---|
| Device Name | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN |
| Applicant | Oxford Laboratories, Inc. |
| Product Code | DEX · Immunology |
| Decision Date | Jul 20, 1976 |
| 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.
