DDY · Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5620 · Class 2
Overview
| Product Code | DDY |
|---|---|
| Device Name | Alpha-2-Macroglobulin, Fitc, 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K790710 | ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN | Kent Laboratories, Inc. | Aug 3, 1979 | SESE |
Top Applicants
- Kent Laboratories, Inc. — 1 clearance
