Product code QZX
- Device name
- Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1650
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
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