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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number k063520
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas pro integrated solutions, cobas c 703  {Mycophenolic Acid} 
CR260305 K063520 Mycophenolic acid Toxicology / TDM MODERATE 05/06/2026
Roche Diagnostics, cobas c 303  {Mycophenolic Acid} 
CR220440 k063520 Mycophenolic acid Toxicology / TDM MODERATE 12/05/2022
Roche Diagnostics cobas c 503 analytical unit  
CR200050 K063520 Mycophenolic acid Toxicology / TDM MODERATE 02/21/2020
Roche Diagnostics cobas c 502 Analyzer  
K100853 K063520 Mycophenolic acid Toxicology / TDM MODERATE 01/10/2011
Roche Diagnostics cobas c 311 Analyzer  
K063520 K063520 Mycophenolic acid Toxicology / TDM MODERATE 07/16/2009
Roche Diagnostics cobas c501 Analyzer  
K063520 K063520 Mycophenolic acid Toxicology / TDM MODERATE 06/07/2007
Roche Diagnostics Cobas Integra 400 Plus  
K063520 K063520 Mycophenolic acid Toxicology / TDM MODERATE 03/29/2007
Roche Diagnostics Cobas Integra 400  
K063520 K063520 Mycophenolic acid Toxicology / TDM MODERATE 02/22/2007
Roche Diagnostics Cobas Integra 800  
K063520 K063520 Mycophenolic acid Toxicology / TDM MODERATE 02/22/2007
Roche Diagnostics Cobas Integra 700  
K063520 K063520 Mycophenolic acid Toxicology / TDM MODERATE 02/22/2007

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