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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number K253839
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas e 801 Analyzer  {Elecsys Anti-SARS-CoV-2} 
CR260007 K253839 SARS-CoV-2 antibodies General Immunology MODERATE 02/02/2026
Roche Diagnostics, cobas e 402 Analyzer  {Elecsys Anti-SARS-CoV-2} 
CR260007 K253839 SARS-CoV-2 antibodies General Immunology MODERATE 02/02/2026
Roche Diagnostics, cobas e 411 Analyzer  {Elecsys Anti-SARS-CoV-2} 
CR260007 K253839 SARS-CoV-2 antibodies General Immunology MODERATE 02/02/2026
Roche Diagnostics, cobas e 602 Analyzer  {Elecsys Anti-SARS-CoV-2} 
CR260007 K253839 SARS-CoV-2 antibodies General Immunology MODERATE 02/02/2026

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