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Data / Medical devices / Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Cardiac C-Reactive Protein, Antigen, Antiserum, And Control (NQD): 15 FDA-registered makers in 6 countries

15 establishments in 6 countries are registered with the FDA to make Cardiac C-Reactive Protein, Antigen, Antiserum, And Control (product code NQD, Class 2, 21 CFR 866.5270). 11 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on April 2, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 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
NQD
Device class
2
Regulation
866.5270
Medical specialty
Immunology

Makers by country

CountryMakers
United States7
Germany3
United Kingdom2
Ireland1
Italy1
Switzerland1

Makers of Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

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
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer4January 18, 2024000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3January 18, 2024000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer2June 21, 2007000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer2April 2, 2026000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesSpecification developer2December 26, 2006010api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer2January 18, 2024000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandManufacturer1August 22, 2005000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1August 25, 2004000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1August 25, 2004000api.fda.gov
Sentinel CH. SPAMilano, ItalyManufacturer1September 27, 2018000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer1December 22, 2006000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov

Updated April 2, 2026. 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.