FDA-cleared cardiac CRP assays

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August 2006
Feature Story

Anne Paxton

As of July 2006, the FDA has cleared eight hsCRP assays for cardiac risk assessment:

  • Stratus CS Acute Care CardioPhase HSCRP Test-Pak, Dade Behring Inc.
  • C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments, Roche Diagnostics Corp.
  • Dimension CardioPhase High Sensitivity CRP Flex reagent cartridge, Dade Behring Inc.
  • Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators, Osr6199; Olympus Crp L, Olympus America Inc.
  • Tina-Quant RP (Latex) HS, Roche Diagnostics Corp.
  • Vitros Chemistry Products hsCRP Reagent, Vitros C, Ortho-Clinical Diagnostics Inc.
  • Olympus CRP Latex Immunoturbidimetric Reagent, Olympus America Inc.
  • N High Sensitivity CRP, Dade Behring Inc.

Other applications are pending. To check assays that have been cleared for cardiac risk assessment, see the FDA website. Search for NQD under the product code field.

Anne Paxton is a writer in Seattle.		  

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