21 CFR 862.2310 — Clinical Sample Concentrator
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2310
Identification
A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.
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 |
|---|---|---|---|---|
| JJH | Clinical Sample Concentrator | 1 | 15 | |
| OUL | Thermocycler, Generic | 1 | 0 | |
| PEG | Nucleic Acid Quantitation Kit | 1 | 0 |
