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FDA PRODUCT CODE · CLASS II

QBH — Lower Respiratory Microbial Nucleic Acid Detection System

Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3985
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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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