21 CFR 866.5425 — Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5425
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DAW | Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control | 1 | 0 | |
| DBC | Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control | 1 | 0 | |
| DEF | Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control | 1 | 1 | |
| DEJ | Alpha-2-Glycoproteins, Antigen, Antiserum, Control | 1 | 0 |
