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Roche: FDA Clearance with CLIA Waiver and CE Mark for its First Point-of-Care Test for Diagnosing Bordetella Infections, Including Whooping Cough

Roche: FDA Clearance with CLIA Waiver and CE Mark for its First Point-of-Care Test for Diagnosing Bordetella Infections, Including Whooping Cough

Impacting News December 3, 2025

Roche in the NEWS

Basel, December 2, 2025 - Roche (RHHBY) announced that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification.

The . . .

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Impacting News
December 3, 2025

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