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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number CW250006
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Acon Laboratories, Inc., Flowflex Plus Strep A Rapid Test Cassette  
CW250006 K251697 Streptococcus, group A Bacteriology WAIVED 11/26/2025
Acon Laboratories, Inc., Flowflex Plus Strep A Rapid Test Strip  
CW250006 K251697 Streptococcus, group A Bacteriology WAIVED 11/26/2025

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