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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 75 Results
Document Number K011878
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Beckman Coulter, Inc., DxC 500i Clinical Analyzer  {Siemens Healthcare Diagnostics, Inc., Syva Emit tox Salicylic Acid Assay} 
CR250127 K011878 Salicylates Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® tox™ Salicylic Acid Assay} 
CR230612 K011878 Salicylates Toxicology / TDM MODERATE 10/30/2023
Siemens Viva-ProE  
CR140294 K011878 Salicylates Toxicology / TDM MODERATE 05/14/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR170670 K011878 Salicylates Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit tox Salicylic Acid Assay} 
CR170670 K011878 Salicylates Toxicology / TDM MODERATE 01/18/2018
ELITECH Clinical Systems Selectra ProM  {Siemens EMIT tox Salicylic Acid} 
CR150226 K011878 Salicylates Toxicology / TDM MODERATE 07/29/2015
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® 2000 Vancomycin Assay} 
K011878 K020692 Vancomycin Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® tox Salicylic Acid Assay} 
K011878 K011878 Salicylates Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® 2000 Tobramycin Assay} 
K011878 K003341 Tobramycin Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® 2000 Theophylline Assay} 
K011878 K011166 Theophylline Toxicology / TDM MODERATE 12/06/2012

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