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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number CR250729
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Ortho Clinical Diagnostics, VITROS 3600 Immunodiagnostic System  {VITROS Immunodiagnostic Products hs Troponin I Reagent Pack} 
CR250729 K252393 Troponin-I (cardiac) General Chemistry MODERATE 02/06/2026
Ortho Clinical Diagnostics, VITROS XT 7600 Integrated System  {VITROS Immunodiagnostic Products hs Troponin I Reagent Pack} 
CR250729 K252393 Troponin-I (cardiac) General Chemistry MODERATE 02/06/2026

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