21 CFR 866.5600 — Lipoprotein, Low-Density, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5600
Identification
A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 2 | 42 | 3rd Party |
| NOE | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 | 2 | 8 | 3rd Party |
| NTV | Myeloperoxidase, Immunoassay, System, Test | 2 | 2 | 3rd Party |
