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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 27 Results
Document Number K913190
 
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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 2000 Phenobarbital Assay} 
CR250127 K913190 Phenobarbital Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® 2000 Phenobarbital Assay} 
CR230612 K913190 Phenobarbital Toxicology / TDM MODERATE 10/30/2023
Ortho-Clinical Diagnostics VITROS XT7600 Integrated System  {Siemen SYVA EMIT 2000 Phenobarbital Assay} 
CR190789 K913190 Phenobarbital Toxicology / TDM MODERATE 01/28/2020
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR170670 K913190 Phenobarbital Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit 2000 Phenobarbital Assay} 
CR170670 K913190 Phenobarbital Toxicology / TDM MODERATE 01/18/2018
Siemens Healthcare Diagnostics ADVIA Chemistry XPT System  
CR160519 K913190 Phenobarbital Toxicology / TDM MODERATE 10/24/2016
ELITECH Clinical Systems Selectra ProM  {Siemens EMIT 2000 Phenobarbital} 
CR150226 K913190 Phenobarbital Toxicology / TDM MODERATE 07/29/2015
Siemens Viva-ProE  
CR150008 K913190 Phenobarbital Toxicology / TDM MODERATE 02/05/2015
Ortho-Clinical Diagnostics VITROS 4600 Chemistry System  {SYVA EMIT 2000 PHENOBARBITAL ASSAY} 
CR140196 K913190 Phenobarbital Toxicology / TDM MODERATE 07/09/2014
Ortho-Clinical Diagnostics VITROS 5600 Chemistry System  {SYVA EMIT 2000 PHENOBARBITAL ASSAY} 
CR140196 K913190 Phenobarbital Toxicology / TDM MODERATE 07/09/2014

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