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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number K961824
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas pro integrated solutions, cobas c 703  {ONLINE TDM Digoxin} 
CR260306 K961824 Digoxin Toxicology / TDM MODERATE 05/06/2026
Roche Diagnostics, cobas c 303  {ONLINE TDM Digoxin} 
CR220440 k961824 Digoxin Toxicology / TDM MODERATE 12/05/2022
Roche Diagnostics cobas c 503 analytical unit  
CR200029 K961824 Digoxin Toxicology / TDM MODERATE 02/19/2020
Roche Diagnostics cobas c 502 Analyzer  
K100853 K961824 Digoxin Toxicology / TDM MODERATE 01/10/2011
Roche Diagnostics cobas c 311 Analyzer  
K961824 K961824 Digoxin Toxicology / TDM MODERATE 04/06/2009
ROCHE DIAGNOSTICS COBAS INTEGRA  
K961824 K961824 Glycosylated Hemoglobin (Hgb A1c) General Chemistry MODERATE 12/06/1996

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