NQD

19 FDA 510(k) clearances · Product code

FDA profile

Official device name

Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Device class

Class II (moderate risk)

Regulation

21 CFR 866.5270

Medical specialty

Immunology

Flags

Third-party review eligible

FDA definition

In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

Adverse events (MAUDE)

2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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