DAJ · Free Secretory Component, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5380 · Class 2
Overview
| Product Code | DAJ |
|---|---|
| Device Name | Free Secretory Component, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5380 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
A free secretory component immunological test system is a device that consists of the reagents used to measure by immunochemical techniques free secretory component (normally a portion of the secretory IgA antibody molecule) in body fluids. Measurement of free secretory component (protein molecules) aids in the diagnosis or repetitive lung infections and other hypogammaglobulinemic conditions (low antibody levels).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
