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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 44 Results
Document Number K031004
 
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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 Amphetamines Assay} 
CR250299 K031004 Amphetamines Toxicology / TDM MODERATE 06/04/2025
Beckman Coulter, Inc., DxC 500i Clinical Analyzer  {Siemens Healthcare Diagnostics, Inc., Syva Emit II Plus Amphetamines Assay} 
CR250127 K031004 Amphetamines Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® II Plus Amphetamines Assay} 
CR230612 K031004 Amphetamines Toxicology / TDM MODERATE 10/30/2023
Siemens Viva-ProE  
CR140294 K031004 Amphetamines Toxicology / TDM MODERATE 05/14/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR170670 K031004 Amphetamines Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit II Plus Amphetamines Assay} 
CR170670 K031004 Amphetamines Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® II Plus Amphetamines Assay} 
K011878 K031004 Amphetamines Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU480 Chemistry Analyzer  {Siemens Syva Emit II Plus Amphetamines Assay} 
K994005 K031004 Amphetamines Toxicology / TDM MODERATE 06/04/2012
Roche Diagnostics Hitachi 717  {Siemens Syva Emit II Plus Amphetamines Assay} 
K031004 K031004 Amphetamines Toxicology / TDM MODERATE 06/28/2011
Roche Diagnostics Hitachi 747  {Siemens Syva Emit II Plus Amphetamines Assay} 
K031004 K031004 Amphetamines Toxicology / TDM MODERATE 06/28/2011

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