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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K221605
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Siemens Healthcare Diagnostics Inc., Atellica DT 250 Analyzer  {Siemens Healthcare Diagnostics Inc., Syva Emit II Plus Buprenorphine Assay} 
CR250299 K221605 Buprenorphine Toxicology / TDM MODERATE 06/04/2025
Beckman Coulter, Inc., DxC 500i Clinical Analyzer  {Siemens Healthcare Diagnostics, Inc., Syva Emit II Plus Buprenorphine Assay} 
CR250127 K221605 Buprenorphine Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit II Plus Buprenorphine Assay} 
CR220202 K221605 Buprenorphine Toxicology / TDM MODERATE 08/09/2023

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