BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
Device Facts
| Record ID | K933078 |
|---|---|
| Device Name | BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT |
| Applicant | Beckman Instruments, Inc. |
| Product Code | MGA · Immunology |
| Decision Date | Jan 11, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5400 |
| Device Class | Class 1 |
Regulatory Classification
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.
