← FDA Medical Device Classifications
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown