FDA product code QZX

Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

Microbiology·Class 2·21 CFR 866.1650
US regulatory classifications
US Product Code (FDA)
QZX
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.1650
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.