DEF · Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5425 · Class 1
Overview
| Product Code | DEF |
|---|---|
| Device Name | Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5425 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
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 |
|---|---|---|---|---|
| K924186 | LPIA-FERRITIN ASSAY | Seradyn, Inc. | Dec 23, 1992 | SESE |
Top Applicants
- Seradyn, Inc. — 1 clearance
