NHX · Class II · 21 CFR 866.5775

FDA Product Code NHX: Antibodies, Anti-cyclic Citrullinated Peptide (ccp)

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.

Leading manufacturers include Inova Diagnostics, Inc., Bio-Rad Laboratories and Roche Diagnostics.

21
Total
21
Cleared
177d
Avg days
2002
Since

FDA 510(k) Cleared Antibodies, Anti-cyclic Citrullinated Peptide (ccp) Devices (Product Code NHX)

21 devices
1–21 of 21
Cleared Sep 21, 2015
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
K143754
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Apr 04, 2013
IMMULITE 2000 ANTI-CCP IGG ASSAY
K121576
Siemens Healthcare Diagnostics, Inc.
Immunology · 309d
Cleared Oct 26, 2011
MULTI-ANALYTE DETECTION SYSTEMS
K112810
Bio-Rad Laboratories
Immunology · 29d
Cleared Aug 24, 2010
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K093954
Bio-Rad Laboratories
Immunology · 244d
Cleared Sep 11, 2008
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
K081338
Roche Diagnostics
Immunology · 121d
Cleared Mar 05, 2008
QUANTA LITE CCP3.1 IGG/IGA ELISA
K072944
Inova Diagnostics, Inc.
Immunology · 140d
Cleared Nov 23, 2005
QUANTA LITE CCP3 IGG ELISA
K052264
Inova Diagnostics, Inc.
Immunology · 96d
Cleared Apr 29, 2002
QUANTA LITE CCP ELISA
K020414
Inova Diagnostics, Inc.
Immunology · 81d

About Product Code NHX - Regulatory Context