21 CFR 862.1470 — Chromatographic Derivative, Total Lipids
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1470
Identification
A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CFB | Chromatographic Derivative, Total Lipids | 1 | 0 | |
| CFD | Sulfophosphovanillin, Colorimetry, Total Lipids | 1 | 4 |
