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 Axis-Shield Diagnostics, Ltd., Inova Diagnostics, Inc. and Bio-Rad Laboratories.

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 Aug 04, 2016
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
K153551
Axis-Shield Diagnostics Limited
Immunology · 237d
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 18, 2011
AXIS-SHIELD ANTI-CCP
K110296
Axis-Shield Diagnostics, Ltd.
Immunology · 198d
Cleared Aug 24, 2010
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K093954
Bio-Rad Laboratories
Immunology · 244d
Cleared Mar 05, 2010
THERATEST EL-ANTI-CCP/2
K090753
Theratest Laboratories, Inc.
Immunology · 350d
Cleared Sep 25, 2009
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
K083868
Axis-Shield Diagnostics, Ltd.
Immunology · 270d
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 Mar 20, 2007
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
K063347
Axis-Shield Diagnostics, Ltd.
Immunology · 134d
Cleared Nov 23, 2005
QUANTA LITE CCP3 IGG ELISA
K052264
Inova Diagnostics, Inc.
Immunology · 96d
Cleared Oct 09, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285
Axis-Shield Diagnostics, Ltd.
Immunology · 23d
Cleared Jul 23, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516
Axis-Shield Diagnostics, Ltd.
Immunology · 74d
Cleared Apr 29, 2002
QUANTA LITE CCP ELISA
K020414
Inova Diagnostics, Inc.
Immunology · 81d

About Product Code NHX - Regulatory Context