NHXClass II

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

21 CFR 866.5775 / Immunology

NHX is the FDA product code for Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp), a class II device type, regulated under 21 CFR 866.5775. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 21 510(k) clearances under this code, the most recent dated 2016-08-04, and 9 recalls.

Classification record

Product code: NHX
Device name: Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
FDA 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.
Regulation: 21 CFR 866.5775
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 21
Ingested recalls: 9

Clearances, product code NHX

By decision year

21 clearances under product code NHX with a decision year between 2002 and 2016, 2002 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code NHX by decision year
Year	Clearances
2002	3
2005	2
2006	2
2007	2
2008	2
2009	2
2010	3
2011	2
2013	1
2015	1
2016	1

Applicants with the most clearances

Product code NHX

Applicants holding the most 510(k) clearances under product code NHX
Applicant	Clearances
Axis-Shield Diagnostics, Ltd.	6
Inova Diagnostics, Inc.	4
Svar Life Science AB	3
Bio-Rad Laboratories Inc.	2
Eurodiagnostica	1
Euroimmun US Inc.	1
Roche Diagnostics GmbH	1
Siemens Healthcare Diagnostics Inc.	1
Sweden Diagnostics (Us), Inc.	1
Theratest Laboratories, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order