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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number k012359
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas pro integrated solutions, cobas c 703  {Tina-quant Complement C4 Ver.2} 
CR260235 k012359 Complement C4 General Immunology MODERATE 05/06/2026
Roche Diagnostics, cobas c 303  {Tina-Quant Complement C3c ver. 2} 
CR220436 K012359 Complement C4 General Immunology MODERATE 12/05/2022
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 502 Analyzer  
K100853 K012359 Complement C4 General Immunology MODERATE 01/10/2011
Roche Diagnostics cobas c 311 Analyzer  {Roche Diagnostics Tina-quant Complement C4-2 ver.2} 
K012359 K012359 Complement C4 General Immunology MODERATE 02/06/2009
Roche Diagnostics Cobas Integra 400  
K012359 K012359 Complement C4 General Immunology MODERATE 12/17/2001
Roche Diagnostics Cobas Integra 800  
K012359 K012359 Complement C4 General Immunology MODERATE 12/17/2001
Roche Diagnostics Cobas Integra 700  
K012359 K012359 Complement C4 General Immunology MODERATE 12/17/2001

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