21 CFR 866.5130 — Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5130
Identification
An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DEI | Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control | 2 | 2 | 3rd Party |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 2 | 30 | 3rd Party |
| DFB | Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control | 2 | 1 | 3rd Party |
| OBZ | Alpha-1-Antitrypsin Kit, Qualitative Phenotype | 2 | 2 | 3rd Party |
| PZH | Serpina1 Variant Detection System | 2 | 3 | SaMD, 3rd Party |
