# Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
> **Product code: NQD** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5270
## Classification
- **FDA Product Code:** NQD
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5270
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

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

## Market data
- **Cleared 510(k) submissions:** 19
- **Registered establishments:** 24
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NQD)
---
*AI Analytics · CC0 1.0*