CFB · Chromatographic Derivative, Total Lipids
Clinical Chemistry · 21 CFR 862.1470 · Class 1
Overview
| Product Code | CFB |
|---|---|
| Device Name | Chromatographic Derivative, Total Lipids |
| Regulation | 21 CFR 862.1470 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Cleared Devices (0)
No cleared devices on record.
