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    In Vitro Diagnostics

    Tests performed on biological samples outside the body.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    IVDs include immunoassays, molecular diagnostics (PCR, NGS), clinical chemistry, hematology, microbiology, and point-of-care tests. Regulated by FDA's CDRH (CBER for some) and under the EU IVDR in Europe.

    What this means in practice

    Roche Diagnostics, Abbott, Siemens Healthineers, Danaher (Beckman, Cepheid), and Thermo Fisher dominate. Companion diagnostics and oncology MRD are key growth areas. EU IVDR transition has been disruptive.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    AdvaMedDx·1MedTech Dive·1AdvaMed·1
    1. 1
      AdvaMedDx
      Verified
      AdvaMedDxadvameddx.org
    2. 2
      MedTech Dive
      Verified
      MedTech Divemedtechdive.com
    3. 3
      AdvaMed - Industry Reports
      Verified
      AdvaMedadvamed.org

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