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FDA PRODUCT CODE · CLASS II

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

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.1650
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K244044Selux Diagnostics, Inc. · 510k2025-03-28

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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