21 CFR 866.5080 — Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5080
Identification
An alpha -1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha -1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha -1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DFF | Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control | 2 | 1 | 3rd Party |
