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22 Sep 2023
Business & Solutions
bioMérieux submits Dual 510(k) and CLIA-waiver application to FDA for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
bioMérieux, a world leader in the field of in vitro diagnostics, has submitted the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel to U.S. Food and Drug Administration (FDA) for a dual 510(k) clearance and CLIA1-waiver. This panel is already CE-marked (IVDD).
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01 Sep 2023
Financial Information
First-Half 2023 Results
Consolidated sales amounted to €1,770 million in first-half 2023, a robust growth like-for-like of 8.3% from €1,658 million in the prior year.
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27 Jun 2023
Press Release
Jennifer Zinn appointed Executive Vice President of Clinical Operations
Marcy-l’Étoile, France – June 27th, 2023. bioMérieux, a world leader in the field of in vitro diagnostics, announces the appointment of Jennifer Zinn as Executive Vice President of Clinical Operations...
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14 Jun 2023
Appointments
bioMérieux evolves its governance
As of July 1st, 2023, Alexandre Mérieux will become Executive Chairman and Pierre Boulud Chief Executive Officer.
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09 May 2023
Press Release
bioMérieux receives US FDA CLIA-waiver for the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
bioMérieux, a world leader in the field of in vitro diagnostics, has received U.S. Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendments (CLIA) waiver for the fast and accurate multiplex PCR*-based BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. This waiver comes in addition to the 510(k) clearance obtained last April.
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27 Apr 2023
Press Release
bioMérieux – First-Quarter 2023 Business Review
bioMérieux, a world leader in the field of in vitro diagnostics, today releases its business review for the three months ended March 31th, 2023. Consolidated sales totaled €906 million in the first quarter of 2023, up 8.2% from €837 million in the year‑earlier period.