NHX

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Product code

NHX

Device name

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Device class

Class 2

21 CFR

21 CFR 866.5775

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

21 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).