FDA Product Code NQD: Cardiac C-reactive Protein, Antigen, Antiserum, And Control
In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments.
Leading manufacturers include Roche Diagnostics and Siemens Healthcare Diagnostics, Inc..
FDA 510(k) Cleared Cardiac C-reactive Protein, Antigen, Antiserum, And Control Devices (Product Code NQD)
About Product Code NQD - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code NQD since 2004, with 19 receiving FDA clearance (average review time: 100 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
FDA review times for NQD submissions have been consistent, averaging 87 days recently vs 101 days historically.
NQD devices are reviewed by the Chemistry panel. Browse all Chemistry devices →