21 CFR 862.2250 — Columns, Glc
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2250
Identification
A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.
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 § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DII | Columns, Glc | 1 | 5 | |
| DJA | Column Supports, Glc | 1 | 1 | |
| DLG | Coating, Liquid, Glc | 1 | 7 | |
| DMS | Gases, Glc | 1 | 0 | |
| JSQ | Chromatography For Bacterial Identification | 1 | 3 | |
| JXQ | Monitor, U.V., Glc | 1 | 0 | |
| KZQ | Chromatography(Gas), Clinical Use | 1 | 12 |
