21 CFR 862.1415 — Ferrozine (Colorimetric) Iron Binding Capacity
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1415
Identification
An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
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 |
|---|---|---|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 1 | 46 | |
| JQD | Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity | 1 | 0 | |
| JQE | Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity | 1 | 6 | |
| JQF | Bathophenanthroline, Iron Binding Capacity | 1 | 8 | |
| JQG | Radiometric, Fe59, Iron Binding Capacity | 1 | 5 |
