21 CFR 866.5420 — Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5420
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.
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 |
|---|---|---|---|---|
| DEN | Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control | 1 | 2 | |
| DEX | Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control | 1 | 5 | |
| LKL | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | 1 | 11 |
