DEI · Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5130 · Class 2
Overview
| Product Code | DEI |
|---|---|
| Device Name | Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5130 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K840867 | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | Intl. Diagnostic Technology | May 11, 1984 | SESE |
| K772250 | ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | Dec 22, 1977 | SESE |
Top Applicants
- Intl. Diagnostic Technology — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
