Panels › Immunology › Product code NHX · Class 2
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Regulation 866.5775
0510(k)s in 12 months (21 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in NHX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 2016 | K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. Axis-Shield Diagnostics Limited, GB | NHX |
| Sep 21, 2015 | K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 Inova Diagnostics, Inc. | NHX |
| Apr 4, 2013 | K121576 | IMMULITE 2000 ANTI-CCP IGG ASSAY Siemens Healthcare Diagnostics, Inc. | NHX |
| Oct 26, 2011 | K112810 | MULTI-ANALYTE DETECTION SYSTEMS Bio-Rad Laboratories | NHX |
| Aug 18, 2011 | K110296 | AXIS-SHIELD ANTI-CCP Axis-Shield Diagnostics, Ltd., GB | NHX |
| Dec 1, 2010 | K093908 | CCPOINT Euro-Diagnostica AB | NHX |
| Aug 24, 2010 | K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories | NHX |
| Mar 5, 2010 | K090753 | THERATEST EL-ANTI-CCP/2 Theratest Laboratories, Inc. | NHX |
| Nov 19, 2009 | K091657 | IMMUNOSCAN CCPLUS Euro-Diagnostica AB, SE | NHX |
| Sep 25, 2009 | K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 Axis-Shield Diagnostics, Ltd., GB | NHX |
| Sep 11, 2008 | K081338 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP Roche Diagnostics | NHX |
| Mar 5, 2008 | K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA Inova Diagnostics, Inc. | NHX |
| Dec 31, 2007 | K070789 | EUROIMMUN ANTI-CCP ELISA Euroimmun Us, LLC | NHX |
| Mar 20, 2007 | K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 Axis-Shield Diagnostics, Ltd., GB | NHX |
| Dec 4, 2006 | K062045 | EDIA ANTI-CCP Euro-Diagnostica AB, SE | NHX |
| Aug 3, 2006 | K061165 | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 Sweden Diagnostics (Us), Inc. | NHX |
| Dec 12, 2005 | K052133 | IMMUNOSCAN RA ANTI-CCP TEST SYSTEM Eurodiagnostica | NHX |
| Nov 23, 2005 | K052264 | QUANTA LITE CCP3 IGG ELISA Inova Diagnostics, Inc. | NHX |
| Oct 9, 2002 | K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA Axis-Shield Diagnostics, Ltd., GB | NHX |
| Jul 23, 2002 | K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 Axis-Shield Diagnostics, Ltd., GB | NHX |
| Apr 29, 2002 | K020414 | QUANTA LITE CCP ELISA Inova Diagnostics, Inc. | NHX |
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