21 CFR 862.2230 — Ion-Exchange Chromatography
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2230
Identification
A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.
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 |
|---|---|---|---|---|
| DJY | Ion-Exchange Chromatography | 1 | 11 | |
| DKO | Adsorbents, Ion-Exchange | 1 | 1 | |
| DMG | Papers, Ion | 1 | 0 | |
| KEA | Resins, Ion-Exchange | 1 | 9 |
