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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K993980
 
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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 Ethyl Alcohol Assay} 
CR250299 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 06/04/2025
Beckman Coulter, Inc., DxC 500i Clinical Analyzer  {Siemens Healthcare Diagnostics, Inc., Syva Emit II Plus Ethyl Alcohol Assay} 
CR250127 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® II Plus Ethyl Alcohol Assay} 
CR230612 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 10/30/2023
Siemens Viva-ProE  
CR140294 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 05/14/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR170670 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit II Plus Ethyl Alcohol Assay} 
CR170670 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 01/18/2018
Siemens Healthcare Diagnostics ADVIA 1200 Chemistry System  
CR160671 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 12/29/2016
Siemens Healthcare Diagnostics ADVIA 1800 Chemistry System  
CR160671 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 12/29/2016
Siemens Healthcare Diagnostics ADVIA 2400 Chemistry System  
CR160671 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 12/29/2016
Siemens Healthcare Diagnostics ADVIA 1650 Chemistry System  
CR160671 K993980 Ethanol (alcohol) Toxicology / TDM MODERATE 12/29/2016

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