21 CFR 862.2750 — Station, Pipetting And Diluting, For Clinical Use
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2750
Identification
A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.
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 |
|---|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 140 | |
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 1 | 3 | |
| QBZ | Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma | 1 | 0 | SaMD |
