ROCHE APOLIPOPROTEIN STANDARD
Device Facts
| Record ID | K910553 |
|---|---|
| Device Name | ROCHE APOLIPOPROTEIN STANDARD |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | DER · Immunology |
| Decision Date | May 8, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5580 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).
