QBZ · Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
Clinical Chemistry · 21 CFR 862.2750 · Class 1
Overview
| Product Code | QBZ |
|---|---|
| Device Name | Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma |
| Regulation | 21 CFR 862.2750 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
