LPIA-FERRITIN ASSAY
Device Facts
| Record ID | K924186 |
|---|---|
| Device Name | LPIA-FERRITIN ASSAY |
| Applicant | Seradyn, Inc. |
| Product Code | DEF · Immunology |
| Decision Date | Dec 23, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5425 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An alpha-2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to electrophoresis) in serum and other body fluids. Measurement of alpha-2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.
