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From compliance to complexity: the impact of in vitro diagnostic regulation for clinical microbiology laboratories

Sangeeta Gaja-Lachman1, Mariëlle Visser-Timmermans1, Diana Langerak1

  • 1Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.

Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases
|January 21, 2026
PubMed
Abstract

Keywords:
Diagnostic testsIn vitro diagnostic test regulationIn-house developed testLaboratory developed testValidation

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