IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
Device Facts
| Record ID | K863868 |
|---|---|
| Device Name | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT |
| Applicant | Cooper Biomedical, Inc. |
| Product Code | DFF · Immunology |
| Decision Date | Feb 13, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5080 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An alpha -1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha -1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha -1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.
