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Data / Medical devices / Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) (NHX): 17 FDA-registered makers in 4 countries

17 establishments in 4 countries are registered with the FDA to make Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) (product code NHX, Class 2, 21 CFR 866.5775). 12 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on August 4, 2016, and lists 7 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
NHX
Device class
2
Regulation
866.5775
Medical specialty
Immunology

Makers by country

CountryMakers
United States7
Germany5
Sweden3
United Kingdom2

Makers of Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Specification developer3October 26, 2011000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer3September 21, 2015000api.fda.gov
Axis-Shield Diagnostics, Ltd.DUNDEE Scotland, United KingdomContract manufacturer, Manufacturer2August 18, 2011010api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2August 4, 2016000api.fda.gov
Euroimmun Medizinische Labordiagnostika AGLuebeck Schleswig-Holstein, GermanyManufacturer1December 31, 2007000api.fda.gov
EUROIMMUN Medizinische Labordiagnostika AGDassow Mecklenburg-Western Pomerania, GermanyManufacturer1December 31, 2007000api.fda.gov
Phadia ABUppsala, SwedenManufacturer1August 3, 2006000api.fda.gov
Phadia ABUppsala, SwedenComplaint file establishment, Manufacturer1August 3, 2006000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer1September 11, 2008000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer1April 4, 2013000api.fda.gov
Svar Life Science ABMALMO Skane, SwedenContract manufacturer, Manufacturer1November 19, 2009010api.fda.gov
Theratest Laboratories, Inc.Lombard, IL, United StatesManufacturer1March 5, 2010000api.fda.gov
Bio-Rad Laboratories, Inc.Woodinville, WA, United StatesContract manufacturer0000api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer for export0000api.fda.gov
Phadia GMBHFREIBURG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov

Updated August 4, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.