ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
Device Facts
| Record ID | K802610 |
|---|---|
| Device Name | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT |
| Applicant | Hyland Therapeutic Div., Travenol Laboratories |
| Product Code | DER · Immunology |
| Decision Date | Jan 5, 1981 |
| 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).
