# Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
> **Product code: QBZ** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2750
## Classification
- **FDA Product Code:** QBZ
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.2750
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Instrument used to create pools of whole blood, whole blood lysates, serum, and /or plasma, for use in blood donor screening tests. May include sample preparation steps such as lysing of whole blood samples.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QBZ)
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