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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K993985
 
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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 Benzodiazepine Assay} 
CR250299 K993985 Benzodiazepines Toxicology / TDM MODERATE 06/04/2025
Beckman Coulter, Inc., DxC 500i Clinical Analyzer  {Siemens Healthcare Diagnostics, Inc., Syva Emit II Plus Benzodiazepine Assay} 
CR250127 K993985 Benzodiazepines Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® II Plus Benzodiazepine Assay} 
CR230612 K993985 Benzodiazepines Toxicology / TDM MODERATE 10/30/2023
Siemens Viva-ProE  
CR140294 K993985 Benzodiazepines Toxicology / TDM MODERATE 05/14/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR170670 K993985 Benzodiazepines Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit II Plus Benzodiazepine Assay} 
CR170670 K993985 Benzodiazepines Toxicology / TDM MODERATE 01/18/2018
ELITECH Clinical Systems Selectra ProM  {Siemens EMIT tox Serum Benzodiazepine} 
CR150226 K993985 Benzodiazepines Toxicology / TDM MODERATE 07/29/2015
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® II Plus Benzodiazepine Assay} 
K011878 K993985 Benzodiazepines Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU480 Chemistry Analyzer  {Siemens Syva Emit II Plus Benzodiazepine Assay} 
K994005 K993985 Benzodiazepines Toxicology / TDM MODERATE 06/04/2012
Beckman Coulter AU640  {Siemens Syva Emit II Plus Benzodiazepine Assay} 
K993985 K993985 Benzodiazepines Toxicology / TDM MODERATE 05/13/2011

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