DFF · Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5080 · Class 2
Overview
| Product Code | DFF |
|---|---|
| Device Name | Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5080 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863868 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT | Cooper Biomedical, Inc. | Feb 13, 1987 | SESE |
Top Applicants
- Cooper Biomedical, Inc. — 1 clearance
