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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number CW240028
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Document Parent Analyte Analyte Specialty Complexity Effective Date
BIOFIRE Diagnostics, BIOFIRE SPOTFIRE System  {BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini} (For use with throat swab)
CW240028 K243544 Respiratory Bacterial Pathogens Bacteriology WAIVED 08/14/2025
BIOFIRE Diagnostics, BIOFIRE SPOTFIRE System  {BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini} (For use with anterior nasal and nasopharyngeal swabs)
CW240028 K243544 SARS-CoV-2 and other Respiratory viruses Virology WAIVED 08/14/2025

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