DEJ · Alpha-2-Glycoproteins, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5425 · Class 1
Overview
| Product Code | DEJ |
|---|---|
| Device Name | Alpha-2-Glycoproteins, 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 (0 of 0)
No cleared devices on record.
