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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K070900
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics cobas c 503 analytical unit  {The Binding Site Group Ltd., Freelite Human Kappa Free Kit For use on the Roche Cobas c systems} (Quantitative)
CR250754 K070900 Kappa light chains General Immunology MODERATE 01/27/2026
Roche Diagnostics cobas c 503 analytical unit  {The Binding Site Group Ltd., Freelite Human Lambda Free Kit For use on the Roche Cobas c systems} (Quantitative)
CR250754 K070900 Lambda light chains General Immunology MODERATE 01/27/2026
Roche Diagnostics, cobas c 303  {The Binding Site Group Ltd., Freelite Human Kappa Free Kit For use on the Roche Cobas c systems} (Quantitative)
CR250754 K070900 Kappa light chains General Immunology MODERATE 01/27/2026
Roche Diagnostics, cobas c 303  {The Binding Site Group Ltd., Freelite Human Lambda Free Kit For use on the Roche Cobas c systems} (Quantitative)
CR250754 K070900 Lambda light chains General Immunology MODERATE 01/27/2026
Roche Diagnostics cobas c 502 Analyzer  {The Binding Site Freelite Human Kappa Free Kit} (Quantitative)
K070900 K070900 Kappa light chains General Immunology MODERATE 10/19/2011
Roche Diagnostics cobas c 502 Analyzer  {The Binding Site Freelite Human Lambda Free Kit} (Quantitative)
K070900 K070900 Lambda light chains General Immunology MODERATE 10/19/2011
Roche Diagnostics Cobas Integra 800  
K070900 K070900 Kappa light chains General Immunology MODERATE 01/26/2009
Roche Diagnostics Cobas Integra 800  
K070900 K070900 Lambda light chains General Immunology MODERATE 01/26/2009
Roche Diagnostics Cobas Integra 400  {FREELITE Human Kappa Free Kit on Roche Cobas Integra 400/400plus} (Quantitative)
K070900 K070900 Kappa light chains General Immunology MODERATE 12/06/2007
Roche Diagnostics Cobas Integra 400 Plus  {FREELITE Human Lambda Free Kit on Roche Cobas Integra 400/400plus} (Quantitative)
K070900 K070900 Lambda light chains General Immunology MODERATE 12/06/2007

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