# Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
> **Product code: QZX** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1650
## Classification
- **FDA Product Code:** QZX
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.1650
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.

## Market data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QZX)
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