Product code
NHX: Antibodies, anti-cyclic citrullinated peptide (ccp)
FDA product code · Class II · Immunology
Key facts
| Product code | NHX |
|---|---|
| Device | Antibodies, anti-cyclic citrullinated peptide (ccp) |
| Device class | Class II |
| Regulation number | 866.5775 |
| Review panel | Immunology |
| Medical specialty | Immunology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database