21 CFR 862.1575 — Ammonium Molybdate And Ammonium Vanadate, Phospholipids
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1575
Identification
A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.
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 |
|---|---|---|---|---|
| CEL | Ammonium Molybdate And Ammonium Vanadate, Phospholipids | 1 | 3 | |
| CEQ | Molybdenum Blue Method, Phospholipids | 1 | 1 | |
| JNS | Stannous Chloride - Hydrazine, Phospholipids | 1 | 0 | |
| JNT | Chromatographic, Phospholipids | 1 | 3 |
