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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number CR200052
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics cobas c 503 analytical unit  {Tina-quant Ferritin Gen.4} 
CR200052 K100538 Ferritin General Chemistry MODERATE 02/19/2020
Roche Diagnostics cobas c 503 analytical unit  {Tina-quant Haptoglobin Gen.2} 
CR200052 K972639 Haptoglobin General Chemistry MODERATE 02/19/2020
Roche Diagnostics cobas c 503 analytical unit  {Roche Diagnostics Tina-quant Complement C4-2 ver.2} 
CR200052 K012359 Complement C4 General Immunology MODERATE 02/19/2020
Roche Diagnostics cobas c 503 analytical unit  {Tina-quant IgA Gen.2} 
CR200052 K040435 Immunoglobulins IgA General Immunology MODERATE 02/19/2020

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