Brief: BioMérieux Receives U.S. FDA CLIA-Waiver For BIOFIRE SPOTFIRE Respiratory (R) Panel Mini

Biomerieux SA

09/05/2023 17:13

May 9 (Reuters) - Biomerieux SA  BIOX.PA :
    * BIOMÉRIEUX RECEIVES US FDA CLIA-WAIVER FOR BIOFIRE®
SPOTFIRE®
RESPIRATORY (R) PANEL MINI
    * THIS WAIVER COMES IN ADDITION TO THE 510(K) CLEARANCE
OBTAINED
LAST APRIL.
    * CLIA-WAIVER ALLOWS BIOFIRE® SPOTFIRE® SYSTEM AND ITS TWO
EXISTING RESPIRATORY PANELS TO BE USED BY NON-LAB PROFESSIONALS
AT POINT-OF-CARE
    * BIOFIRE® SPOTFIRE® SYSTEM WITH PANELS WILL FURTHER EXPAND
BIOMÉRIEUX’S PRESENCE IN UNITED STATES CLIA-WAIVED MARKET
    * RECEIVED U.S. FDA CLINICAL LABORATORY IMPROVEMENT
AMENDMENTS
(CLIA) WAIVER FOR FAST AND ACCURATE MULTIPLEX PCR*-BASED
BIOFIRE® SPOTFIRE® RESPIRATORY (R) PANEL MINI

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