DDT · Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5620 · Class 2
Overview
| Product Code | DDT |
|---|---|
| Device Name | Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5620 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
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 the limitations in § 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 the limitations in § 866.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
