21 CFR 866.5120 — Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5120
Identification
An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 6 | 3rd Party |
| NJF | Antibodies, Anti-Actin, Anti-Smooth Muscle | 2 | 1 | 3rd Party |
