TINA-QUANT ALPHA-1 ANTITRYPSIN
Device Facts
| Record ID | K010978 |
|---|---|
| Device Name | TINA-QUANT ALPHA-1 ANTITRYPSIN |
| Applicant | Rochdiag |
| Product Code | DEM · Immunology |
| Decision Date | May 18, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5130 |
| Device Class | Class 2 |
Regulatory Classification
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.
