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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number k241220
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas pro integrated solutions, cobas c 703  {Tina-quant Lipoprotein (a) Gen.2 Molarity} 
CR260235 k241220 Lipoprotein(a) (Lp(a)) General Chemistry MODERATE 05/06/2026
Roche Diagnostics cobas c 303 Analyzer  {Tina-quant Lipoprotein (a) Gen.2 Molarity} 
CR250308 K241220 Lipoprotein(a) (Lp(a)) General Chemistry MODERATE 06/11/2025
Roche Diagnostics cobas c 501 Analyzer  {Tina-quant Lipoprotein (a) Gen.2 Molarity} 
CR250308 K241220 Lipoprotein(a) (Lp(a)) General Chemistry MODERATE 06/11/2025
Roche Diagnostics cobas c 502 Analyzer  {Tina-quant Lipoprotein (a) Gen.2 Molarity} 
CR250308 K241220 Lipoprotein(a) (Lp(a)) General Chemistry MODERATE 06/11/2025
Roche Diagnostics cobas c 311 Analyzer  {Tina-quant Lipoprotein (a) Gen.2 Molarity} 
CR250308 K241220 Lipoprotein(a) (Lp(a)) General Chemistry MODERATE 06/11/2025
Roche Diagnostics cobas c 701 analyzer  {Tina-quant Lipoprotein (a) Gen.2 Molarity} 
CR250308 K241220 Lipoprotein(a) (Lp(a)) General Chemistry MODERATE 06/11/2025
Roche Diagnostics cobas c 702 analyzer  {Tina-quant Lipoprotein (a) Gen.2 Molarity} 
CR250308 K241220 Lipoprotein(a) (Lp(a)) General Chemistry MODERATE 06/11/2025
Roche Diagnostics cobas c 503  {Tina-quant Lipoprotein(a) Gen.2 Molarity} 
CR240233 K241220 Lipoprotein(a) (Lp(a)) General Chemistry MODERATE 02/03/2025

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