FDA Product Code
FDA Product Code NHX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5775
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | Axis-Shield Diagnostics Limited | 2016-08-04 | Traditional | PDF ↗ |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | Inova Diagnostics, Inc. | 2015-09-21 | Traditional | PDF ↗ |
| K121576 | IMMULITE 2000 ANTI-CCP IGG ASSAY | Siemens Healthcare Diagnostics, Inc. | 2013-04-04 | Traditional | PDF ↗ |
| K112810 | MULTI-ANALYTE DETECTION SYSTEMS | Bio-Rad Laboratories | 2011-10-26 | Special | PDF ↗ |
| K110296 | AXIS-SHIELD ANTI-CCP | Axis-Shield Diagnostics, Ltd. | 2011-08-18 | Traditional | PDF ↗ |
| K093908 | CCPOINT | Euro-Diagnostica AB | 2010-12-01 | Traditional | PDF ↗ |
| K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | 2010-08-24 | Traditional | PDF ↗ |
| K090753 | THERATEST EL-ANTI-CCP/2 | Theratest Laboratories, Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K091657 | IMMUNOSCAN CCPLUS | Euro-Diagnostica AB | 2009-11-19 | Traditional | PDF ↗ |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | Axis-Shield Diagnostics, Ltd. | 2009-09-25 | Traditional | PDF ↗ |
| K081338 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP | Roche Diagnostics | 2008-09-11 | Traditional | PDF ↗ |
| K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA | Inova Diagnostics, Inc. | 2008-03-05 | Traditional | PDF ↗ |
| K070789 | EUROIMMUN ANTI-CCP ELISA | Euroimmun Us, LLC | 2007-12-31 | Traditional | PDF ↗ |
| K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 | Axis-Shield Diagnostics, Ltd. | 2007-03-20 | Traditional | PDF ↗ |
| K062045 | EDIA ANTI-CCP | Euro-Diagnostica AB | 2006-12-04 | Traditional | PDF ↗ |
| K061165 | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 | Sweden Diagnostics (Us), Inc. | 2006-08-03 | Traditional | PDF ↗ |
| K052133 | IMMUNOSCAN RA ANTI-CCP TEST SYSTEM | Eurodiagnostica | 2005-12-12 | Traditional | PDF ↗ |
| K052264 | QUANTA LITE CCP3 IGG ELISA | Inova Diagnostics, Inc. | 2005-11-23 | Traditional | PDF ↗ |
| K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | Axis-Shield Diagnostics, Ltd. | 2002-10-09 | Traditional | PDF ↗ |
| K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 | Axis-Shield Diagnostics, Ltd. | 2002-07-23 | Traditional | PDF ↗ |
| K020414 | QUANTA LITE CCP ELISA | Inova Diagnostics, Inc. | 2002-04-29 | Traditional | PDF ↗ |
Product code NHX · Class II · Immunology. Data: openFDA.