MGA · Alpha-1 Microglobulin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5400 · Class 1
Overview
| Product Code | MGA |
|---|---|
| Device Name | Alpha-1 Microglobulin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5400 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
An alpha-globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.
Classification Rationale
Class I (general 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K965033 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT | Beckman Instruments, Inc. | Apr 21, 1997 | SESE |
| K933078 | BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT | Beckman Instruments, Inc. | Jan 11, 1994 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 2 clearances
