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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number k040431
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas pro integrated solutions, cobas c 703  {Tina-quant IgM Gen.2} 
CR260235 k040431 Immunoglobulins IgM General Immunology MODERATE 05/06/2026
Roche Diagnostics, cobas c 303  {Tina-Quant IgM Gen.2} 
CR220436 K040431 Immunoglobulins IgM General Immunology MODERATE 12/05/2022
Roche Diagnostics cobas c 503 analyzer  {Tina-quant IgM Gen.2} 
CR200098 K040431 Immunoglobulins IgM General Immunology MODERATE 03/16/2020
Roche Diagnostics cobas c 702 analyzer  
K100853 K040431 Immunoglobulins IgM General Immunology MODERATE 09/01/2011
Roche Diagnostics cobas c 502 Analyzer  
K100853 K040431 Immunoglobulins IgM General Immunology MODERATE 01/10/2011
Roche Diagnostics cobas c 701 analyzer  
K100853 K040431 Immunoglobulins IgM General Immunology MODERATE 01/10/2011
Roche Diagnostics cobas c 311 Analyzer  {Tina-quant IgM Gen.2} 
K040431 K040431 Immunoglobulins IgM General Immunology MODERATE 02/25/2009
ROCHEDIAGNOSTICS HITACHI 902  {Tina-quant IgM Gen.2} 
K040431 K040431 Immunoglobulins IgM General Immunology MODERATE 03/10/2004
Roche Diagnostics Hitachi 904  {Tina-quant IgM Gen.2} 
K040431 K040431 Immunoglobulins IgM General Immunology MODERATE 03/10/2004
Roche Diagnostics Hitachi 911  {Tina-quant IgM Gen.2} 
K040431 K040431 Immunoglobulins IgM General Immunology MODERATE 03/10/2004

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